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

FDA Pre-Market Approval

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Alto Abdominal Stent Graft System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNCHRONY, SOLUS, PHOENIX, PARAGON AND TRILOGY FAMILY OF PULSE GENERATORS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS SUPRA-ANNULAR (S.A.V.) BIOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ELLIPSE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS BRAF V600 MUTATION TEST

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY CRT-D

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·UNIFY, UNIFY ASSURA, UNIFY QUADRA, AND QUADRA ASSURA CRT-DS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRI VASCULAR, INC. OVATION /OVATION ABDOMINAL STENT GRAFT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled Ablation Catheter and Cable