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C315: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED. C304: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

C315 Delivery System: The Medtronic C315 Delivery System contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations. SelectSite C304 Deflectable Catheter System: The SelectSite C304 Deflectable Catheter System contains a single deflectable catheter, deflectable catheter dilator, universal slitter, valve, guidewire, needle, and syringe. The SelectSite C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access to venous insertion site, the guidewire to access the vein, the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite C304 Deflectable Catheter System is available in three models which are the C304-S59, C304-L69, and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.

The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors. The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through third-party intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU. The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

Affera Integrated Mapping System: The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen. Magnetic Localization Patch Kit: Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Affera Integrated Mapping System: The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive electromagnetic sensors embedded in the catheter. In addition to magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors. The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU. The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface. Magnetic Localization Patch Kit: The Magnetic Localization Patch Kit is an accessory device that includes 2 surface localization patches and is used with the Affera Integrated Mapping System for electromagneticbased tracking and navigation only. The patches are placed in fixed positions in contact with the patient's skin and provide a provide a stable mounting point for magnetic sensors within the intended connecting cable, which are used to provide information regarding patient position and movement during electromagnetic-based tracking and navigation procedures.

Affera Integrated Mapping System: The Affera Integrated Mapping System is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen. Impedance Localization Patch Kit: Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Affera Integrated Mapping System: The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive electromagnetic sensors embedded in the catheter. In addition to magneticbased tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors. The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU. The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface. Impedance Localization Patch Kit: The Impedance Localization Patch Kit is an accessory device used with the Affera Integrated Mapping System that includes 6 surface localization patches. Patches are placed in fixed positions in contact with the patient's skin to deliver low energy patient auxiliary signals to enable the integrated mapping system to allow visualization of catheters that do not contain electromagnetic location sensors, and to support detection of respiratory motion and to provide information regarding patient position and movement.

The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.

The Amplatz Goose Neck Snare kit (Snare device) contains the snare, snare catheter, snare introducer, and torque device. The snare is made of a nitinol cable and a gold-plated tungsten loop. The preformed snare loop can be introduced through catheters without risk of snare deformation because of the snare's superelastic construction. The snare catheter contains a platinum-iridium, radiopaque marker band.

The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases: · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias · patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. To manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.

Affera Mapping System: The Affera mapping system is intended to be used for catheter based cardiac electrophysiological mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including intracardiac electrograms, may also be recorded and displayed on the system's display screen. Location Reference Patch Kit: Refer to the instructions for use accompanying the compatible navigation-enabled electrophysiology catheter that is used with the compatible mapping system for the specific indications for use.

Affera Mapping System (AFR-00003): The Affera Mapping System (mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of one or more magnetic sensors connected to cardiac catheters. The mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic sensors embedded in the catheter. The Affera Mapping System connects to electrophysiology (EP) catheter lab equipment such as the EP recording system and external stimulators. The mapping system can also be connected to third-party intracardiac (IC) catheters to display electrograms from and deliver pacing stimuli. The mapping system can be used with cardiac ablation systems for tracking and navigation of magnetic sensor-equipped catheters during ablation procedures. When used with the Affera Ablation System, the mapping system displays ablation data on the workstation user interface. Location Reference Patch Kit (AFR-00007): The Location Reference Patch (LRP) Kit is a disposable device sold separately from the mapping system. The LRP Kit includes two non-sterile single-use patches, each containing a passive magnetic location sensor, which are placed in fixed positions on the patient's body surface (one anterior (A-patch) and one posterior (P-patch) to detect respiratory motion and to provide information regarding patient position and movement, respectively. The LRP Kit employs a hydrogel adhesive material for skin contact and for repositioning/ reapplication, and which is intended for extended duration topical use.

The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

The LINQ II ICM is an insertable automatically-activated and patient activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases: - · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias - patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINO II ICM includes the following accessories: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420 and CareLink SmartSync LINQ II ICM Application Model D00U024. New to the LINQ II ICM system is the CareLink SmartSync LINQ II Platform Application Model D00U027.

The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.

The Cosine-10 Diagnostic Catheter is a sterile, single-use, steerable decapolar mapping catheter with a bidirectional deflecting tip intended for electrophysiological mapping of cardiac structures (i.e., stimulation and recording). The catheter contains 10 electrodes spaced in 5 pairs, including a distal dome electrode. Two electrode spacing configurations are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All catheter electrodes may be used for recording or stimulation. The catheter can be used with a compatible introducer sheath (7.5Fr minimum).