Implantable Cardioverter/ Defibrillator - India CDSCO Medical Device Registration
Implantable Cardioverter/ Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000402_2dfb325dcaa32647b8b7c7dc9431e812_7b6f9f22e333daef7bc195fe24764605. 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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Brand Name
Enticos
License Holder
Biotronik Medical Devices India Pvt Ltd.Device Class
Approving Authority
CDSCO
Product Information
Rivacor is an implantable cardioverter/defibrillator (Enticos). Primary objective of this ICD is the prevention of sudden cardiac death. Furthermore, the 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 sequentialpacing (Enticos)
IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Implantable Pacemaker
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Implantable Pacemaker
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Implantable Pacemaker
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
STEROID ELUTING ICD LEAD WITH ACTIVE FIXATION
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Bipolar, steroid eluting endocardial lead
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Implantable Cardioverter/ Defibrillator
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Implantable Cardioverter/ Defibrillator
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Implantable Cardiac Monitor
Brand: Enticos
Biotronik Medical Devices India Pvt Ltd.
Aspiration Catheter
Brand: 3Flow
IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS
Brand: Enticos
Implantable Pacemaker
Brand: Enticos
Implantable Pacemaker
Brand: Enticos
Implantable Pacemaker
Brand: Enticos
STEROID ELUTING ICD LEAD WITH ACTIVE FIXATION
Brand: Enticos
Bipolar, steroid eluting endocardial lead
Brand: Enticos
Implantable Cardioverter/ Defibrillator
Brand: Enticos
Implantable Cardioverter/ Defibrillator
Brand: Enticos
Implantable Cardiac Monitor
Brand: Enticos