Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization

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

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIPLOS MODEL 03

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II™ Bioprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·PSW 1703.U

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Implantable Infusion System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·polymacon Soft (Hydrophilic) Extended Wear Contact Lenses

Leadless Pacemaker

FDA Pre-Market Approval

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

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX HBsAg Qual; LIAISON XL MUREX Control HBsAg Qual; LIAISON XL MUREX HBsAg Confirmatory

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Percepta Serena Solara App

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis