Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Bowel)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERFLEX (LIBERTE) CORONARY STENT SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTALLIN ADVANCER AND CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Ablation Catheter, Sensor Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Essentio, Proponent, and Accolade MRI Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryGel Silicone Gel-Filled Breast Implants

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval

FDA Class 3 ·Symplicity G3 Renal Denervation RF Generator

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Valve System

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF CRT-D'S

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHETIC

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·ARTISAN-VERISYSE MYOPIA PHAKIC IOL

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS