Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX MODELS 4143/4144/4145/4243/4244/4245 ACTIVE-FIXATION, STEROID ELUTING, ENDOCARDIAL PACING LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6998 IS-1 LEAD PORT PLUG

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILES OF ICD DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKERS DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI;

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CRT LEADS (MODELS 1156T, 1158Y AND 1258T).

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

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, Implantable Cardioverter, with Cardiac Resynchronization (Crt-D); Defibrillator, Implantable, Dual-Chambe

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

FDA Pre-Market Approval

FDA Class 3 ·ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T