Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ANTERIOR CHAMBER IOLS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI UNIPOLAR/BIOPOLAR LEADS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ARTEFILL

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

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS INSYNC FAMILIES OF CRT-ICDS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·SUPERION INTERSPINOUS SPACER

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE INJECTABLE IMPLANT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX