Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Application Software for Micra Transcatheter Pacing System MC1VR01

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon B soft contact lenses for extended wear

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM SACRAL NERVE STIMULATION THERAPY FOR BOWEL CONTROL

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA FAMILY FOR DEEP BRAIN STIMULATION -TREMOR CONTROL

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218

Electrode, Stabilized Epidural Spinal

FDA Pre-Market Approval

FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·EUCLID SYSTEMS ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY