Tissue Heart Valve - India CDSCO Medical Device Registration
Tissue Heart Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000026_5769b6c3ec17ac85568541fbcbbdbbaa_1af5e4e6cf1e9c190b814bdaf58c656d. This device is marketed under the brand name Epic Valve Aortic and Mitral. 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
Epic Valve Aortic and Mitral
License Holder
M/s St. Jude Medical India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
The valve is intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve. The valve may also be used as a replacement for a previously implanted aortic prosthetic heart valve.
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