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Quadripolar lead for electrical stimulation - India CDSCO Medical Device Registration

Quadripolar lead for electrical stimulation is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000419_5a7eb337ffe80404d7e608823b78ecab_a72f21fb9fb604728dc83ac8e9b29748. This device is marketed under the brand name Interstim. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Quadripolar lead for electrical stimulation
UID: IMP/MD/2021/000419_5a7eb337ffe80404d7e608823b78ecab_a72f21fb9fb604728dc83ac8e9b29748

Brand Name

Interstim

Device Class

Class D

Approving Authority

CDSCO

Product Information

Sacral neuromodulation therapy provided by the InterStimโ„ข system is indicated for the management of the following chronic intractable (Interstim) disorders of the pelvis and lower urinary or intestinal tract: overactive bladder, fecal incontinence, and nonobstructive urinary retention

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