Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA/CONSULTA CRT-P

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING CAND AND APPLICATOR SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·TRANSCEND® Hip Articulation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ABSORBING ANTERIOR CHAMBER INTRAOCULAR LENSES

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·TOP2A FISH PHARMDX KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra Spinal Cord Stimulator (SCS) System

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Evolut PRO+ System and Medtronic Evolut FX System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Silikon 1000

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters