Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK CR2 Defibrillator

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA, SOLETRA

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3, ITREL 4, SYNERGY, SYNERGY VERSITREL, RESTORE, RESTOREPRIME, ADVANCEDRESTORE, ULTRA, ENS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE 2 LVAS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC TRANSVENE LEAD SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE Injectable Implant

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION (VASURFILCON A) SOFT CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon A Soft Contact Lenses for Extended Wear