Transcatheter Heart Valve - India CDSCO Medical Device Registration
Transcatheter Heart Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000345_5f313cd4b1aa3cbe296cc3909c330b1a_01484ce4650501ee52129f103f941b76. This device is marketed under the brand name Trifecta Valve Aortic. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Trifecta Valve Aortic
License Holder
M/s St. Jude Medical India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
The Portico™ valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are considered high surgical risk
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