Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT_P)

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL™ Fibrillar Absorbable Hemostat, SURGICEL SNoW™ Absorbable Hemostat

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA PC IMPLANTABLE NEUROSTIMULATOR

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Deep Brain Stimulation Therapy System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIPLOS MODEL 05 A & B

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN/INSYNC/INSYNC III

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PhysioStim and SpinalStim

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 DR-T and Intica Neo 7 and 5 DR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND ENPULSE E1 IPG

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·CONTIGEN BARD COLLAGEN IMPLANT

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Lung System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Pacing Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Biploar CRT-P. Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P; Sola

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System