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The Intermedics leads which are the subject of this 510(k) Notification are endocardial pacing leads designed for use with implantable pulse generators for long-term cardiac pacing, This indication is identical to the indication for use of the legally marketed predicate devices, the Intermedics Models 430-07 and 432-03 Endocardial Pacing Leads. The indications for ventricular pacing include, but are not limited to: sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal atrioventricular (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.

The Intermedics Model 430-07, 431-07, 432-03, and 433-03 Endocardial Pacing Leads are designed for use with implantable cardiac pulse generators for long-term cardiac pacing. Passed transvenously through the cephalic, subclavian, or jugular vein (external or internal), the tip electrode (cathode) is positioned at the endocardial surface to permit contact with the heart. The tip fixation mechanism consists of four silicone rubber tines. The lead body, which consists of insulated conductor coils, carries electrical impulses from the heart to the pulse generator, resulting in sensing. The lead body also carries impulses from the pulse generator to the endocardial surface, causing cardiac depolarization (pacing), The proximal end of the lead is connected to the header of the implanted pulse generator. The electrodes of the Intermedics Model 430-07, 431-07, 432-03, and 433-03 Endocardial Pacing Leads are made of titanium coated with inidium oxide (IROX™).

The models 436-07 and 437-07 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, symptomatic second-degree 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.

The Intermedics Models 436-07 (bipolar) and 437-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for ventricular applications for long term cardiac pacing. The nominal lead length for the model 436-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal lead length for the model 437-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors. The models 436-07 and 437-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 367-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-81(tapered stylet, limber), and model 365-82 (tapered stylet, firm). The model 437-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter, VS-1 unipolar lead to 6 mm unipolar pacer). The minimum introducer size recommended for both lead models is 10 French. The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719).

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.

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.

The models 438-07 and 435-07 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, symptomatic second-degree 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. 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. 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.

The Intermedics Cardifix™ EZ Models 438-07 (bipolar) and 435-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for atrial or ventricular applications for long term cardiac pacing. The nominal length for the model 438-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal length for the model 435-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors. The models 438-07 and 435-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 365-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-89 ("J" stylet, limber), and model 365-90 ("J" stylet, firm). The model 435-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter. VS-1 unipolar lead to 6 mm unipolar pacer). The minimum introducer size recommended for the model 438-07 is 10 French. The minimum introducer size recommended for the model 435-07 is 7.5 French. The models 438-07 and 435-07 pacing leads are identical to the Intermedics models 438-05 (K922972, K954719) and 435-05 (K922972, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719) except that the dimensions of the cathode tip have been slightly modified to accommodate the active fixation corkscrew.

Pacing leads and accessories 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. Suture-on epicardial leads (model 439-04) and screw-on (sutureless) myocardial leads (model 439-07), placed on the outside of the heart, are indicated for use when cardiac pacing is indicated and a suture-on lead is preferred, or when an endocardial lead cannot achieve satisfactory results. Such leads are particularly well suited to patients whose age or heart condition requires that the potential for lead dislodgment be minimized (i.e. patients who have not reached full physical maturity) and patients who may require cardiac pacing following openchest surgery.

The Intermedics Models 431-04, 431-07, 433-02, 433-03, 435-02, 435-05, 435-07, 435-08, 437-02, and 437-07 endocardial pacing leads, model 439-04 epicardial pacing lead, model 439-07 myocardial pacing lead, implantable accessory models 365-07, 365-09, 365-14, 365-17, 365-19, 365-22, 365-33, 365-34, 365-44, 365-49, 366-13, 366-15, 366-27, 366-28, 366-29, and 366-30, and non-implantable accessory models 365-62, 365-77, 365-29, 366-02, 366-17, and 367-01, are designed for use with implantable cardiac generators for long term cardiac pacing.