Intraocular Lens

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE OTW & TAXUS LIBERTE ATOM OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Platform, CareLink SmartSync Common Application and CareLink SmartSync MRI Host Application

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Element Plus, PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS ELUTING PLATINUM CHROMIUN CORONARY STENT SYSTEM MONORAIL & OVER THE WIRE.

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and COLLASTAT Absorbable Collagen Hemostatic Agemt- Microfibrillar Form

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test