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Drug eluting Stent for Vascular Intervention - India CDSCO Medical Device Registration

Drug eluting Stent for Vascular Intervention is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000232_29ce6a3f9882e11b6805913c5b1f048d_14c02bc460b155ae07ed147236bcc735. This device is marketed under the brand name Pantera. The license holder is Biotronik Medical Devices India Pvt Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Drug eluting Stent for Vascular Intervention
UID: IMP/MD/2020/000232_29ce6a3f9882e11b6805913c5b1f048d_14c02bc460b155ae07ed147236bcc735

Brand Name

Pantera

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Orsiro Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (Pantera) in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.

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