Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC (AC1-AC5)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ACTROS AND KAIROS FAMILY OF PULSE GENERATORS WITH LITRONIK BATTERY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PROMOTE AND UNIFY

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

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY AND VARIOUS FAMILIES OF CURRENT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TVL(TM) LEAD SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS FAMILY OF PULSE GENERATORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Aaris intraocular lens model EC-3 and EC-3 PAL