Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO™ System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Isoflex Low Voltage Lead

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RX ZETA, OTW ZETA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE, RADIESSE LOW VISCOSITY

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS 2 OTW

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead