CDSCO UID IMP/MD/2021/000402_2dfb325dcaa32647b8b7c7dc9431e812_764c53b92223d3325b13e2f07459a7d8

Implantable Cardioverter/ Defibrillator

Biotronik Medical Devices India Pvt Ltd.·Device Class Class D·India CDSCO·Brand: Enticos
Registration details
UID
IMP/MD/2021/000402_2dfb325dcaa32647b8b7c7dc9431e812_764c53b92223d3325b13e2f07459a7d8
Device class
Class D
Brand name
Enticos
Approving authority
CDSCO
Product information
Intica Neo is a cardioverter/defibrillator (Enticos). Primary objective of this ICD is the prevention of sudden cardiac death. Furthermore, this device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing (Enticos). The implantation of an ICD is a symptomatic therapy with the following objectives: - Termination of spontaneous ventricular fibrillation (Enticos) through shock delivery - Termination of spontaneous ventricular tachycardia (Enticos) through antitachycardia pacing (Enticos); in case of ineffective ATP or hemodynamically not tolerated VT, with shock delivery - Cardiac resynchronization through multisite ventricular pacing (Enticos) - Compensation of bradycardia through ventricular (Enticos) or AV sequential pacing (Enticos)
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About this record

Implantable Cardioverter/ Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000402_2dfb325dcaa32647b8b7c7dc9431e812_764c53b92223d3325b13e2f07459a7d8. This device is marketed under the brand name Enticos. The license holder is Biotronik Medical Devices India Pvt Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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