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

FDA Pre-Market Approval

FDA Class 3 ·Accolade Cardiac Resynchronization Therapy Pacemaker Devices- Valitude, Valitude X4, Visionist and Visionist X4

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750; PARADYM RF CRT-D 9750; PARADYM RF BCRT-D9750; INTENSIA CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 System

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS