Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG, RVDR01

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA, VERSA IPG, ENRHYTHM IPG, RELIA IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Transvene CS/SVC Lead

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ISOMED INFUSION SYSTEM

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7250 ARRHYTHMIA MANAGEMENT DEVICE

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON-TB Gold Plus

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace® RNS® System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

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-P