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

FDA Pre-Market Approval

FDA Class 3 ·U125 VALITUDE™ CRT-P, U128 VALITUDE™ X4 CRT-P, U225 VISIONIST™ CRT-P, U226 VISIONIST™ CRT-P, U228 VISIONIST™ X4 CRT-P

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

FDA Pre-Market Approval

FDA Class 3 ·(CRT-P Resynchronization Devices) INVIVE, INTUA, VISIONIST, VALITUDE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK PATIENT MONITOR, MYCARELINK READER FIELD REPLACEMENT UNIT (FRU), MYCARELINK SMART PATIENT READER, CARELINK EN

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 Plus Assay

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

FDA Pre-Market Approval

FDA Class 3 ·Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT-

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECT SECURE LEAD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·INTERTACH TM IMPLANTABLE PACEMAKER PULSE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·OCTAPOLAR EXTENSION/SPECIFY SURGICAL LEAD KIT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·N.C.G.T. GRAFT

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS