CDSCO UID IMP/MD/2022/000455_340e223b064b19e7b5d6e48d0f69c87d_5d272d55d44aa6c9718e47cc2b424d4f

Epicardial implantable leads

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·Device Class Class D·India CDSCO·Brand: Myopore Bipolar Sutureless Pacing lead
Registration details
UID
IMP/MD/2022/000455_340e223b064b19e7b5d6e48d0f69c87d_5d272d55d44aa6c9718e47cc2b424d4f
Device class
Class D
Brand name
Myopore Bipolar Sutureless Pacing lead
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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About this record

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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