Strata - India CDSCO Medical Device Registration
Strata is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000481_c56824838185cbcb5d334a91a4026335_7bb6d3f83da11567cc421d4be2014485. This device is marketed under the brand name Strata NSC Valve. 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 C. The approving authority is CDSCO.
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Brand Name
Strata NSC Valve
Device Class
Approving Authority
CDSCO
Product Information
The Strata II valve is a shunt component designed to provide continued cerebrospinal fluid (Strata NSC Valve) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata II valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.
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