Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA FAMILY OF PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Setrox S 53; Safio S 53; Dextrus 4136;TILDA R53;Solia S 45/53/60, JT 45/53; Siello S53/60/45/53/60/,JT 45/53;

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS, SETROX S, TILDA, SAFIO S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PMS-600 PROGRAMMER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 2303.U, NEO 2303.U

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S45, S53, S60 and Solia S45, S53, S60

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent, Implantable

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Peripheral Self-Expanding Nitinol Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS AND CARDIAC AIRBAG FAMILIES

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW/STRATOS LV/LV-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR-

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS & LUMOS FAMILIES OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T

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

FDA Pre-Market Approval

FDA Class 3 ·Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Phylax ICD System