Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERTICALLY INTEGRATING BATTERY FEEDTHRU ASSEMBLY

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

FDA Pre-Market Approval

FDA Class 3 ·INVIVE AND INTUA CRT-PS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO AND VITALIO PACEMAKERS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 855 REFILL KIT

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Vercise PC, and Vercise Gevia, Deep Brain Stimulation (DBS) Systems

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR, INVIVE AND INTUA CRT-P'S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK P2 PACEMAKER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV/PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA, ENERGEN, & INCEPTA ICD'S

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELUTE LEAD SYSTEM

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEADS