Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ORCHESTRA PROGRAMMER

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750 (ZL102),INTENSIA CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM (VR/DR) 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF (VR/DR) 9750,INTENSIA (VR 124/DR 154)

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

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW REMOTE MONITORING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW hotspot

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750, PARADYM RF CRT-D 9750

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

FDA Pre-Market Approval

FDA Class 3 ·SITUS OTW UW28D LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY/ESPRIT PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ORCHESTRA PROGRAMMER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR AND PARADYM VR/DR ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·Paradym RF CRT-d 9750, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium 4 LV CRT-D 1744

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

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator CRT-Ds

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply DR

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY AND ELA RHAPSODY PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ALIZEA and CELEA pacemakers, Remote monitoring software (RMS)