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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Quard CRT-D; Brava CRT-D, Quard CRT-D; Claria MRI CRT-D, Quard CRT-DCompia MRI CRT-D, Quard CRT-D; Con

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead; Vitatron Brilliant S+ vdd Lead

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead, Performa Lead

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·THERMA CHOICE UTERINE BALLON THERAPY SYSTEM

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATETER

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS, GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6943 AND 6945

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Comfilcon A Soft (Hydrophilic) contact lenses for extended wear

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System