Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE EZ IS-1 ACTIVE FIZATION LEAD MODELS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera NRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP,Z,Z NOVUS,SP NOVUS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIC

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DURATA FAMILY OF HIGH VOLTAGE LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART SD, VIGILA, VOLTA