Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit LP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Attesta MRI, Sphera MRI, Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Cochlear Implant System

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EXCIMER LASER SYSTEM EC-5000

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER II

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Novi Spinal Cord Stimulator (SCS) System

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

FDA Pre-Market Approval

FDA Class 3 ·Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-Ds

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System