Bipolar, steroid eluting endocardial lead - India CDSCO Medical Device Registration

Bipolar, steroid eluting endocardial lead is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000402_794101a96e0ba210253d22ec26764604_73503a7c0115c0a17d0ec412e6e11681. 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

Bipolar, steroid eluting endocardial lead

UID: IMP/MD/2021/000402_794101a96e0ba210253d22ec26764604_73503a7c0115c0a17d0ec412e6e11681

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 pacemaker or ICD the Solia S leads are indicated for the following:  Permanent sensing and pacing in the right ventricle or the right atrium. With its active fixation screw, this lead is especially suited for positioning in the atrium and for patients with deteriorating ventricular trabeculae for whom passive fixation with silicone tines is not possible. In combination with a compatible pacemaker or ICD the Solia T/JT leads are indicated for the following:  Permanent sensing and pacing in the right ventricle (Enticos) or atrium (Enticos)

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IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

Brand: Enticos

Biotronik Medical Devices India Pvt Ltd.

Bipolar, steroid eluting endocardial lead - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

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IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

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