Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·OCUFILCON D EXTENDED WEAR LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GST (MINILINK TRANSMITTER) & GSR (CGMS I PRO RECORDER)

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF FAMILY CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TVL LEAD SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·ND:YAG POSTERIOR CAPSULOTOMY MODEL 100

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENOUS DEFIBRILLATION LEAD

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NU VASIVE PCM CERVICAL DISC SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flassh Glucose Monitoring System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-Poece Multifocal

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ Photodynamic D-Light C PDD System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDOLOGIX, INC. POWERLINK SYSTEM