Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY DC+ MODEL 2318L PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APS III MODEL 3500 PROGRAMMER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APS III PROGRAMMER WITH SOFTWARE MODEL 3302 REV.D (V1.04)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT MODEL 7276

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III MODEL 8042 AND INSYNC III MODEL 9981 APPLICATION SOFTWARE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·APS III PROGRAMMER WITH MODEL 3303 SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY DR & AFFINITY SR PULSE GENERATORS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed™ III Pump

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM III AT MODEL 7276 (ICD)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Infusion System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Foldable Acrylic IOL with OptiEdge

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters