Pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, and certain conditions of asymptomatic second-degree block.

In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.

In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.

Active fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease.

Device Description

The Intermedics Models 430-07, 432-03, 436-02, 436-07, 438-05, and 438-07 endocardial pacing leads are designed for use with implantable cardiac generators for long term cardiac pacing. With the exception of the solution used during the manufacturing process, the listed pacing leads manufactured with the CFC-free process are identically configured to the commercially available Intermedics pacing leads with the same model numbers. The general characteristics of the pacing leads include electrodes, lead body, tip fixation, and connector assembly.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Intermedics pacing leads, specifically focusing on the new CFC-free manufacturing process.

It’s important to note that this 510(k) summary, typical for medical devices in 1996, focuses heavily on demonstrating equivalence to a predicate device rather than establishing novel safety and effectiveness from scratch. Therefore, many of the performance metrics and study designs common in modern AI/ML device submissions are not directly applicable or present.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Material Biocompatibility	Absence of toxic liability under physiological conditions; continued biocompatibility after manufacturing process change.	Hemolysis Test: No toxic liability found. MEM Elution Cytology: No toxic liability found. Ames Mutagenicity: No toxic liability found. USP Class V: No toxic liability found. Intramuscular Implantation Test: No toxic liability found. Maximization Sensitization Test: No toxic liability found. USP Pyrogen Test: No toxic liability found. Repeated for IPA/heptane cleaned materials (Silicone, 80A Polyurethane, 55D Polyurethane): Results indicate continued biocompatibility.
Manufacturing Process Safety	Maintain biocompatibility of materials after switching to IPA/heptane cleaning.	Demonstrated by repeated hemolysis and cytotoxicity tests on materials cleaned with the new IPA/heptane blend.
Pacing Lead Performance Equivalence	Expected performance equivalent to commercially available Freon-TMS manufactured leads.	Qualification testing on model 430-07 (representative of process changes) demonstrated that performance is expected to be equivalent. The document indicates "similarity in design and materials" (with the exception of the cleaning agent) as a basis for expecting comparable efficacy.
Clinical Performance (Long-Term)	Low incidence of clinical complications; effective performance in human implantation.	The predicate devices (commercially available leads manufactured with Freon-TMS) had an "extremely low incidence of clinical complications, demonstrating its effective performance in human implantation." The new CFC-free leads are expected to perform with comparable efficacy due to favorable biocompatibility and qualification test results.
Sterilization Efficacy	Sterilization methods meet AAMI guidelines for ethylene oxide sterilization.	Intermedics sterilization procedures utilize EO sterilizers set for specific parameters derived using methods described in the 1988 AAMI guideline.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size:
- Biocompatibility: Not explicitly stated as a "sample size" in terms of number of devices. However, the tests were performed on "all of the tissue/fluid contacting materials" and specific material types (silicone, 80A polyurethane, 55D polyurethane) after the manufacturing change. The individual tests (e.g., animal tests for implantation, in vitro tests) would have their own sample sizes, which are not detailed here. For the repeated tests on IPA/heptane cleaned materials, these were performed on "the following materials," implying a material-level test rather than a full product-level "test set."
- Qualification Testing: Performed on a single lead model: Model 430-07. This model was selected as "representative of the changes in the manufacturing processes."
- Clinical Data: No new clinical test set was used for the CFC-free leads. The clinical performance claim relies on the "clinical experience of the commercially available Intermedics pacing leads" (predicate devices).
Data Provenance: The biocompatibility and qualification testing data are prospective, generated specifically for this 510(k) submission. The clinical performance data for predicate devices is retrospective, based on prior commercialization and post-market experience. The country of origin of the data is not specified, but Intermedics Inc. is based in Angleton, TX, USA, suggesting testing was likely conducted in the US or by its chosen test laboratories.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this submission. The device is a physical medical device (pacing lead) and not an AI/ML diagnostic or predictive tool that relies on expert interpretation for ground truth establishment. The "performance" being evaluated is material biocompatibility, physical and electrical function, and manufacturing process validation, not diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is not based on expert interpretation of results that would require adjudication. Test results for biocompatibility and qualification would be interpreted against predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. This is a submission for a physical medical device (pacing lead), not an AI-assisted diagnostic or decision support system. Therefore, no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an algorithm or software-only device.

7. The Type of Ground Truth Used

For Biocompatibility: The "ground truth" is established by standard, validated biological and chemical test methodologies (e.g., ISO standards or USP monographs for hemolysis, cytotoxicity, implantation tests, pyrogen tests, etc.). The expected outcome (e.g., "no toxic liability") serves as the ground truth.
For Qualification Testing: The "ground truth" is the established performance characteristics of the predicate device (Freon-TMS manufactured leads). The new leads are tested to ensure their performance (e.g., electrical properties, mechanical strength if tested) is equivalent to these established characteristics.
For Clinical Performance: The "ground truth" for clinical effectiveness and safety is derived from the established long-term clinical outcomes and low complication rates of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/Machine Learning device that requires a training set. The "training" for this device would be the manufacturing process development and optimization, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of an AI/ML device.

Summary

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K962174

AUG 21 1996

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

(To be completed by FDA)

트 트 트 트 트 트

A. GENERAL INFORMATION	2
B. DESCRIPTION OF THE DISEASES AND CONDITIONS FOR WHICH THECFC-FREE PACING LEADS ARE INDICATED	3
C. DEVICE DESCRIPTION	4
1. Labeling	6
2. Design and Materials	7
3. Performance	9
D ALTERNATIVES	9
E. POTENTIAL ADVERSE EFFECTS	10
F. SUMMARY OF STUDIES	10
1. Biocompatibility Studies	10
2. Qualification Testing	11
G. CLINICAL SUMMARY	12
H. MANUFACTURING/STERILIZATION	12
I. CONCLUSION	13

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510(K) Notification - CFC-Free Manufacturing Process SECTION 2 - 510(K) SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

팀 및 목록 필

GENERAL INFORMATION A.

Device Classification Name:

Electrode, Pacemaker, Permanent and Temporary

Device Trade Name:

Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead I
Intermedics Model 432-03 Bipolar Implantable Endocardial Pacing Lead 내
Intermedics Model 436-02 Bipolar Implantable Endocardial Pacing Lead 를
Intermedics Model 436-07 Bipolar Implantable Endocardial Pacing Lead 트
Intermedics Cardifix EZ Model 438-05 Bipolar Implantable Endocardial i Pacing Lead
Intermedics Cardifix EZ Model 438-07 Bipolar Implantable Endocardial u Pacing Lead ん

Applicant's Name and Address:

Intermedics Inc. (Establishment Registration Number: 1640319) 4000 Technology Drive Angleton, TX 77515

Primary Company Representative:

Lori Kleinschrodt Holder, RAC Regulatory Affairs Specialist (409) 848-4522 FAX: (409) 848-4533

Alternate Company Representative:

Kathleen M. Chester, RAC Senior Regulatory Affairs Specialist (409) 848-4527 FAX: (409) 848-4533

Date of Notification:

June 4, 1996

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DESCRIPTION OF THE DISEASES AND CONDITIONS FOR WHICH THE CFC-FREE B. MANUFACTURED PACING LEADS ARE INDICATED

The indications for use of Intermedics Models 430-07, 432-03, 436-02, 436-07, 438-05, and 438-07 endocardial pacing leads, manufactured using a Chlorofluorocarbon (CFC) Free process, are identical to those for the commercially available leads with the same model numbers manufactured using Freon-TMS.

In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.

Contraindications

The use of endocardial leads may be contraindicated in the presence of tricuspid atresia. Ebstein's malformation, and various forms of atrial or ventricular transposition, and in patients with mechanical tricuspid heart valves. The use of endocardial leads for atrial indications may be contraindicated in the presence of atrial paralysis, atrial atrophy, or a surgically modified or excised atrial appendage.

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510(K) Notification - CFC-Free Manufacturing Process SECTION 2 - 510(K) SUMMAY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

Atrial pacing is contraindicated in the presence of atrial fibrillation and, except when used in a dual chamber system, in the presence of certain A-V conduction defects.

를 일 일 일 일 일

C. DEVICE DESCRIPTION

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510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS
ORTIFICATION - CFC-FREE MANUFACTURAL CE ADVERSE SAFETY 510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS
SECTION 2 - 510(K) SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

터 및 및 로 발

	Lead Model							Lead Model	510(k) Number
Accessory	430-07	432-03	436-02	436-07	438-05	438-07	430-07	K890412	3/28/89
365-11Limber Stylet	✓	✓	✓	✓	✓	✓		K902672	3/1/91
365-12Firm Stylet	✓	✓	✓	✓	✓	✓		K954610	Submitted 10/03/95
365-57Limber Large "J" Stylet					✓			K954719	2/27/96
365-58Firm Large "J" Stylet					✓		432-03	K890411	03/28/89
365-81Tapered Limber Stylet				✓				K912235	09/26/91
365-82Tapered Firm Stylet				✓				K954610	Submitted 10/03/95
365-87Limber Tight "J" Stylet					✓			K954719	2/27/96
365-89Limber "J" Stylet						✓	436-02	K883602	09/06/88
365-90Firm "J" Stylet						✓		K954719	02/27/96
366-14Lead Cover							436-07	K955122	Submitted 11/07/95
366-29Step up adapter VS.1 to 5mm							438-05	K922972	01/22/93
366-30Step up adapter VS. 1 to 6mm								K954719	02/27/96
367-01Vein Lifter	✓	✓	✓	✓	✓	✓	438-07	K955550	Submitted 12/04/95
Stylet Funnel(no model no.)	✓	✓	✓	✓	✓	✓

TABLE 1. Accessories packaged with each lead model.

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With the exception of the solution used during the manufacturing process, the listed pacing leads manufactured with the CFC-free process are identically configured to the commercially available Intermedics pacing leads with the same model numbers. Table 2 lists the 510(k) numbers and approval dates for each lead model.

및 '배 '홈 로마 로마

Table 2. 510(k) Numbers and approval dates for each lead model.

1. Labeling

There are no changes to the product labeling as a result of the modification to the manufacturing process.

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발 로 비 일 링

2. Design and Materials

The general characteristics of the pacing leads are summarized below. Table 3 summarizes the characteristics of each lead by model number.

a. Electrodes
The cathode tip electrode transfers the electrical charge from the pulse generator to the desired cardiac surface (endocardium, epicardium, or myocardium) via the pacing lead. This electrical charge stimulates the myocardium, causing cardiac depolarization. The electrodes are either made of iridium-oxide coated titanium (IROX™) (models 430-07, 432-03, 436-07, 438-07), carbon-coated (Biolite1) titanium (model 436-02) or a platinum-iridium alloy (model 438-05).
b. Lead Body
The conductor coils, constructed of three nickel-cobalt alloy wires wound uniaxially (trifilar), transmit electrical activity to and from the heart. Electrical isolation between the connectors and the body environment is provided by an sheath surrounding the conductor coil; which also contributes to the structural strength of the leads. The sheath may be made of polyurethane (models 430-07, 432-03, 438-05, 438-07) or silicone rubber (models 436-02, 436-07).
c. Tip Fixation
The passive fixation mechanism of the lead tip of the models 430-07, 432-03, 436-02, and 436-07 lodges among the trabeculae in order to prevent dislodgement or movement of the tip electrode from the endocardium. The tip fixation mechanism, made of silicone rubber, is a trailing tines design with radial projections 45° to the axis of the lead body.

Biolite is a trademark of Carbomedics, Inc., Austin, TX.

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510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS

SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

월 5일 또 약 1월 1일

Model No.	Chamber1	Polarity	Length2 (cm)	ElectrodeMaterial	Lead BodyMaterial	Fixation	Connector
430-07	Ventricular	Bipolar	58	IROX	Polyurethane	Passive/Tine	VS. 1
432-03	Atrial	Bipolar	52	IROX	Polyurethane	Passive/Tine	VS. 1
436-02	Ventricular	Bipolar	60	Biopore	Silicone	Passive/Tine	VS. 1
436-07	Ventricular	Bipolar	58	IROX	Silicone	Passive/Tine	VS. 1
438-05	A/V	Bipolar	60	Pt/IR	Polyurethane	Active/Screw	VS. 1
438-07	A/V	Bipolar	58	IROX	Polyurethane	Active/Screw	VS. 1

: 下

류 또는 도쿄 제 일

TABLE 3. Characteristics of Intermedics Pacing Leads by Model Number.

'A/V - Atrial and Ventricular

2 Nominal Lengths. Other lengths available upon request.

元 00

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510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

트 및 밀 로 워

The active fixation mechanism of the lead tips of the models 438-05 and 438-07 consists of a nickel-cobalt helical corkscrew which is fixed in the endocardium in order to prevent dislodgement or movement of the tip. The model 438-07 pacing lead has a unique feature which provides a protective soluble Polyethylene Glycol (PEG) capsule over the fixation mechanism while the lead is passed through the venous system. Within 2 to 4 minutes, the PEG dissolves allowing fixation of the lead into the cardiac tissue.

d. Connector Assembly
For all Intermedics pacing lead models, the connector pin (cathode), made of 316 stainless steel, provides the electrical and mechanical connection between the pulse generator and pacing lead. The connector sleeve and seals are made of silicone rubber and provide an insulating seal between the lead and the header of the pulse generator. The connector dimensions are designed to meet the requirements of the VS. 1 standard.

3. Performance

The Intermedics pacing leads are intended for use with implantable pulse generators. Based upon the results of qualification testing, the performance of the leads manufactured with the CFC-free manufacturing process is expected to be equivalent to the performance of the commercially available leads manufactured using Freon-TMS.

D. ALTERNATIVES

The alternatives to the use of pacing leads are similar to those described for pulse generators. Surgery or drug therapy have been stated as alternatives to cardiac pacing in certain instances. However, when a cardiac pacing system is employed, the side effects of drugs and/or the risks of surgery make these alternatives less desirable.

Other commercially available pacing leads provide another alternative to the use of Intermedics pacing leads manufactured using the CFC-free process.

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510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS SECTION 2 - 510(K) SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

내 1위 개 내 비

E. POTENTIAL ADVERSE EFFECTS

The potential adverse effects associated with the use of pacing leads may include intermittent or continuous loss of pacing or sensing produced by factors such as displacement of the electrode, unsatisfactory electrode position, breakage of the conductor or its insulation, an increase in thresholds, or poor electrical connection to the pulse generator. As with the introduction of any foreign object into the body, infection can result from the use of pacing leads and accessories. These complications can occur during implantation, explantation, or at any time postoperatively and may require noninvasive or invasive management techniques.

When subclavian venipuncture is used for endocardial lead introduction, "extremely medial" insertion of a lead and/or "anatomic abnormalities" may contribute to conductor fracture2. Perforation of the ventricular wall may cause phrenic nerve stimulation or diaphragmatic muscle stimulation. Cardiac tamponade has been reported from instances of lead perforation.

When removing an implanted endocardial lead, if the connector is cut off, the lead's insulation tubing, under sufficient traction, may separate from the lead conductor and slide off, leaving an exposed conductor coil in the heart and vein.

When using an epicardial or myocardial lead, conditions may occur that are associated with risks inherent in open chest surgery, such as pulmonary difficulties and, rarely, cardiac tamponade

F. SUMMARY OF STUDIES

1. Biocompatibility Studies

All of the tissue/fluid contacting materials of the pacing leads have been evaluated for biocompatibility in both in vitro and in vivo test systems and subjected to the following tests:

"Stokes K, et al: A possible "new" complication of subclavian stick: Conductor fracture, PACE, 10:748, 1987 (Abstract).

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510(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

동물 및 일본 대

. Hemolysis Test
MEM Elution Cytology
피 Ames Mutagenicity
I USP Class V
Intramuscular Implantation Test I
Maximization Sensitization Test 통
발 USP Pyrogen Test

Based upon the test data, the materials above were not found to present any toxic liability under physiological conditions. Therefore, the tissue/fluid contacting materials of this pacing system are considered biocompatible

In order to ensure continued biocompatibility of these materials when manufactured utilizing the IPA/heptane blend, the hemolysis and cytotoxicity tests were repeated for the following materials:

피 Silicone tubing cleaned with IPA/heptane,
l 80A polyurethane tubing cleaned with IPA/heptane,
55D polyurethane tubing cleaned with IPA/heptane. I

Based upon the results of these tests, the materials continue to be biocompatible when processed with the IPA/heptane blend.

2. Qualification Testing

Qualification testing was performed on the model 430-07. This lead model was selected as it consists of processes representative of the changes in the manufacturing processes of the affected lead models as a result of the elimination of Freon-TMS. These processes include:

Cleaning (degreasing) of silicone, polyurethane, and metal parts ■
페 Swelling of silicone tubing and parts
Softening and lubricating of polyurethane tubing 트
프 Mechanical assembly of components

제 및 일 및 및

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S 10(K) NOTIFICATION - CFC-FREE MANUFACTURING PROCESS SECTION 2 - 510(K) SUMMARY, SUMMARY OF ADVERSE SAFETY AND EFFECTIVENESS DATA, AND CERTIFICATION

부 및 및 공 및 공

G. CLINICAL SUMMARY

The clinical experience of the commercially available Intermedics pacing leads has resulted in an extremely low incidence of clinical complications, demonstrating its effective performance in human implantation. Because of the favorable biocompatibility and qualification test results, it is expected that the pacing leads manufactured with the CFC-free process will perform with comparable efficacy.

H. MANUFACTURING/STERILIZATION

Intermedics utilizes environmental controls in the manufacturing facilities which are designed, maintained and closely monitored to achieve an efficacious environment for manufacturing all products. The manufacturing environment is routinely monitored for particle counts, humidity, temperature, and static electricity controls. Additionally, bioburden testing is performed on all products.

Vendors of purchased material must be "approved" based upon a quality survey in which Intermedics' field engineers determine whether the vendor has the capability of consistently supplying material that will meet Intermedics' standards. Each quantity of purchased material is assigned a lot number and acceptance or rejection is determined based upon an inspection (conducted on a statistical sampling basis) performed to Intermedics' Engineering specifications.

The finished pacing lead and accessories are packaged in the formed pockets of an inner blister tray which is closed by heat sealing a peelable cover around the periphery. This inner blister is then placed into an outer blister which is closed by heat sealing a second peelable cover to it. Cover material is microbial penetration resistant, water resistant, and puncture resistant as suitable for this application.

Intermedics sterilization procedures for pacing leads and accessories utilize ethylene oxide (EO) sterilizers set for specific parameters derived using methods described in the 1988 AAMI guideline, Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices.

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에 올랐으로 바

Upon release from sterilization, pacing lead and accessories are packaged into a carton and the boxed product is inspected prior to being routed to the Finished Goods Inventory area.

I. CONCLUSION

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The information presented in this submission for the Intermedics Models 430-07, 432-03, 436-02, 436-07, 438-05, and 438-07 endocardial pacing leads demonstrates that the intended use of these devices does not differ from that of the commercially available predicate models.

The clinical experience of the Intermedics endocardial pacing leads has resulted in an extremely low incidence of clinical complications, demonstrating their_ effective performance in human implantation. Because of the similarity in decion and materials .the nacino leads can be experted to nerform with

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Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.