Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE CERVICAL DISC

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D & PARADYM RF CRT-D

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

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE CERVICAL DISC

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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO ICD MODELS 614 AND 615

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR/DR/RHAPSODY SR/DR/REPLY VR/DR

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Prestige LP® Cervical Disc

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF VR

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·THE HEART LASER CO2 TMR SYSTEM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·Infuse Bone Graft/Medtronic Interbody Fusion Device

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

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Hip System

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM