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

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 FAMILY OF PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II INFUSION PUMP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/BRILLIANT S+ VDD LEADS/PRODIGY SR/WRENCH KIT/THERA-I/VITATRON LEGACY/LEGACY II/VISA/PACING SYSTEM ANALYZER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta IPG, Versa IPG, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR M

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval

FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL® SNoW™ Absorbable Hemostat

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER, RELIATY, RENAMIC, REOCOR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut Pro System, Medtronic Evolut Pro+ System, Medtronic Evol

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cervista HPV HR Assay

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

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LV LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·LCS® Total Knee System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis