STEROID ELUTING ICD LEAD WITH ACTIVE FIXATION - India CDSCO Medical Device Registration

STEROID ELUTING ICD LEAD WITH ACTIVE FIXATION is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000402_8cf37e482cc4aad251de67f2d5a559b9_51c034746d4126a9846e43c0a856a527. 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

STEROID ELUTING ICD LEAD WITH ACTIVE FIXATION

UID: IMP/MD/2021/000402_8cf37e482cc4aad251de67f2d5a559b9_51c034746d4126a9846e43c0a856a527

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 ICD the Plexa leads are intended for the following: Permanent pacing and sensing in the right ventricle Delivery of defibrillation/cardioversion therapies With its active fixation screw, this lead is especially suitable for patients with degeneratedtrabeculae in the ventricle for whom passive fixation with silicone or polyurethane tines is not possible

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IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

Brand: Enticos

Biotronik Medical Devices India Pvt Ltd.

STEROID ELUTING ICD LEAD WITH ACTIVE FIXATION - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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