Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers.

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR FAMILY OF CRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY AND PROMOTE QUANDRA FAMILY OF ICDS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY VR DF-4 FAMILY OF ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICD AND CRT-D

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF SPINAL CORD STIMULATION SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM II FAMILY OF ICD/PULSE GENERATORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AF-1 Family of Intraocular Lens (IOL)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·INDENTITY & IDENTITY ADX FAMILY OF DEVICES