Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ActaStim-S Spine Fusion Stimulator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ONYX SYSTEM, DEVICE MODEL 7290CX AND SOFTWARE MODEL 9999

Cap, Cooling (Infants)

FDA Pre-Market Approval

FDA Class 3 ·OLYMPIC COOL-CAP

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U

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

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMPS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval

FDA Class 3 ·KONING BREAST CT (MODEL CBCT1000)

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235)

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V-235)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK ENDURANCE RX ENDOCARDIAL DEFIBRILLATION LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9