IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS - India CDSCO Medical Device Registration

IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000402_c185a91aa0c4363c7de7b97295e3a175_a0d4596882b4eac6f1841a2d978e89dc. 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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CDSCO Registered

Class Class D

IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

UID: IMP/MD/2021/000402_c185a91aa0c4363c7de7b97295e3a175_a0d4596882b4eac6f1841a2d978e89dc

Brand Name

Enticos

License Holder

Biotronik Medical Devices India Pvt Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

In combination with a compatible implantable triple-chamber pacemaker or ICD, this lead is intended indicated for the following: •Permanent, transvenous implantation in the coronary venous system via the coronary sinus of the left side of the heart •Permanent sensing and pacing of the left ventricle

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Implantable Pacemaker

Brand: Enticos

Biotronik Medical Devices India Pvt Ltd.

IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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