BIOTRONIK Iperia Implantable Cardioverter Defibrillator

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Dostępny od:

BIOTRONIK ASIA PACIFIC PTE. LTD.

Klasa:

Class D medical device

Wyprodukowano przez:

BIOTRONIK SE & Co. KG

Dziedzina terapeutyczna:

Cardiovascular

Wskazania:

Iperia 5/7 is part of a family of implantable cardioverter defibrillators (ICDs). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: Termination of spontaneous ventricular fibrillation (VF) through shock delivery; Termination of spontaneous ventricular tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with shock delivery; Cardiac resynchronization through multisite ventricular pacing (triple-chamber devices); Compensation of bradycardia through ventricular (single; chamber devices) or AV sequential pacing (DX, dual- and triple-chamber devices)

Podsumowanie produktu:

Device System Info:[Sterile Medical Device], EO sterilization method; Models: Iperia 5 VR-T - 393050, Iperia 5 VR-T DX - 393048, Iperia 5 VR-T DF-4 - 393051, Iperia 5 DR-T - 392418, Iperia 5 DR-T DF-4 - 392419, Iperia 5 HF-T - 393027, Iperia 5 HF-T DF-4 - 393025, Iperia 7 VR-T - 393034, Iperia 7 VR-T DX - 393032, Iperia 7 VR-T DF-4 - 393030, Iperia 7 DR-T - 392409, Iperia 7 DR-T DF-4 - 392423, Iperia 7 HF-T - 393007, Iperia 7 HF-T DF-4 - 393009, Iperia 7 HF-T QP - 401658, Iperia 5 VR-T DX - 393049, BS DF-1 - 119602, BS DF-1 - 395082, BS IS4 - 403724, TW - 108984, TW - 395121, Iperia 7 HF-T QP DF-4 - 401657, Iperia 5 HF-T QP DF-4 - 402656

Data autoryzacji:

2018-11-13