Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® Symfony™, TECNIS® Symfony™ Toric, TECNIS® Symfony™ OptiBlue®, TECNIS® Symfony™ OptiBlue® with TECNIS Simplicity®

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PORCINE BIOPROSTHESIS MODELS 305, 310

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Tridyne Vascular Sealant

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APSU PROGRAMMER, APSU SOFTWARE, BASE STATION

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ZYDERM COLLAGEN IMPLANT (ZYDERM CI)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Endurity MRI, Assurity MRI

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE, CADET, CONTOUR, CONTOUR 11/MD, ADGSTROM II/MD, PROFILEII/MD, PHOTON, PHOTON MICRO

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACCENT PACERS AND ANTHEM RF CRT-P DEVICES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LVAS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY PACEMAKERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS