Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini System

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D, RF CRT-D

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

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

FDA Pre-Market Approval

FDA Class 3 ·PARASYM CRT-D 8750

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator ICDs

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ORCHESTRA PROGRAMMER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM VR 1210/1240, PLATINIUM DR 1510/1540 (ICD)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO 6750 CRT-D

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL 5000

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT Revelation with Tomosynthesis Option System

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Warmer, Blood, Electromagnetic Radiation

FDA classification

FDA Class 3 ·Warmer, Blood, Electromagnetic Radiation

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM