Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COCHLEAR CI500 SERIES IMPLANTS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN TM SULFUR HEXAFLUORIDE (SF6) GAS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant, including RADIESSE Hands, RADIESSE (+) Lidocaine, and RADIESSE (+) Jawline

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSEAL VASCULAR CLOSURE DEVICE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL AF, GEM II AT FAMILY OF ICDS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTAWIRE™ Guidewire

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MemoryGel/MemoryGel Xtra Breast Implants

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK ZETA CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC II PROTECT, INSYNC III PROTECT, INTRINSIC 30, INTRINSIC, INSYNC SENTRY, INSYNC MAXIMO, CONCERTO

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY ABLATION CATHETERS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN TM PERFLUOROPROPANE (C3F8)GAS

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/SENSIA, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700 IPG, KAPPA 900 IPG, ENPULSE IPG, ADAPATA/ VERSA/ SENSIA IPG

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MemoryShape Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Silicone Filled Breast Implants