Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 325 PACEMAKER SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 325 PACEMAKER SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 300 PACEMAKER MAESTRO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 333 PACEMAKER SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PRMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (CMS)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 MONORAIL AND OVER-THE-WIRE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D

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

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2 and SICD MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS

CORDIS MULTICOR II MODEL 402D PACER

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·HeartLogic™