Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT, LEADS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS LEAD, DBS LEAD-REDUCED SPACING

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PERCUTANEOUS EXTENSION KIT

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·LEAD EXTENSION, PERCUTANEOUS EXTENSION KIT AND LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY DEVICES & VENTAK PRISM DEVICES

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Solesta Injectable Gel

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD2, CONTAK RENEWAL/RENEWAL 3/ RENEWAL 3/3HE RF

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Deflux Injectable Gel

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISCOVERY & MERIDIAN DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+/PULSAR COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·AudioStream and AudioKey 2.0

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne