Endocardial Defibrillation lead - India CDSCO Medical Device Registration

Endocardial Defibrillation lead is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000458_835616fabca0a19ea86fe44f751a8322_4fe9e40fa0cb43df2bbd468872ce0bf0. This device is marketed under the brand name RELIANCE 4 FRONT. The license holder is Boston Scientific India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Endocardial Defibrillation lead

UID: IMP/MD/2021/000458_835616fabca0a19ea86fe44f751a8322_4fe9e40fa0cb43df2bbd468872ce0bf0

Brand Name

RELIANCE 4 FRONT

License Holder

Boston Scientific India Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The S-ICD System is intended to provide defibrillation therapy for the treatment of life threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing

Class D

Defibrillator lead

Brand: RELIANCE 4 FRONT

Boston Scientific India Pvt. Ltd.,

Class D

Brand: RELIANCE 4 FRONT

Class D