Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 3

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Home Monitoring System Version 3.52.0

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BILEAFLET-CENTER OPENING CARDIAC VALVE

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass Ultra System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accent MRI Pacemaker

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Left Ventricular Assist System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·BIOENTERICS LAP-BAND

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CERVICAL STIM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL TIME SYSTEM