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

FDA Pre-Market Approval

FDA Class 3 ·Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Device Command Library (DCL), CareLine Express

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Instrument Command Library (ICL), Device Command Library (DCL)

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Telemetry Wand

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TM) LARGE GRANULAR (LG)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·PERI-OSS

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC)

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·ALVEOFORM TM BIOGRAFT