Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TENDRILL STS MODEL 2088TC LEAD

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISSION SPINAL CORD SIMULATOR (SCS) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL ELASTIC/ELASTIMIDE & ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Gore Tigris Vascular Stent

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Accent, Accent MRI, Assurity, Assurity+, Endurity, Endurity Core

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip Delivery System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II™ Left Ventricular Assist System (LVAS)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SelectSecure Lead

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EPIC VASCULAR SELF EXPANDING STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP) Assay

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

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional)