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Epicardial implantable leads - India CDSCO Medical Device Registration

Epicardial implantable leads is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000455_340e223b064b19e7b5d6e48d0f69c87d_5d272d55d44aa6c9718e47cc2b424d4f. This device is marketed under the brand name Myopore Bipolar Sutureless Pacing lead. The license holder is Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Epicardial implantable leads
UID: IMP/MD/2022/000455_340e223b064b19e7b5d6e48d0f69c87d_5d272d55d44aa6c9718e47cc2b424d4f

Brand Name

Myopore Bipolar Sutureless Pacing lead

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Myopore Bipolar Sutureless Myocardial Pacing Lead is indicated for use when ventricular epicardial attachment is required, or when a transvenous lead cannot provide effective pacing. This type of lead is useful in situations where it is required that the potential for lead dislodgement be diminished, or that pacing and/or sensing will be established subsequent to open heart surgery.

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