Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar; Pulsar-18; Pulsar-18 T3

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Phylax AV ICD System

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR/DR-T/VR/VR-T/LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS (TM) CARDIAC PACEMAKER (4.34)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Pulsar-18 T3 Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode and Styley Catheter

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER II

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

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 Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0

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

FDA Pre-Market Approval

FDA Class 3 ·sentus QP LV Lead

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)

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode, Stylet Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW-L BP LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS