Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN CS & ATTAIN OTW & ATTAIN BIPOLAR OTW

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1801.U

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED(TM) INFUSION SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1904.U

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

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

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation Catheter, FARASTAR™ Pulsed Field Ablation

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra App

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI SureScan Lead

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SpinalStim