BIOTRONIK Iperia Implantable Cardioverter Defibrillator

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

BIOTRONIK ASIA PACIFIC PTE. LTD.

수업:

Class D medical device

Manufactured by:

BIOTRONIK SE & Co. KG

치료 영역:

Cardiovascular

치료 징후:

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)

제품 요약:

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

승인 날짜:

2018-11-13