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_1e0b30c4c53fae0362b193132d5b54fa. 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_1e0b30c4c53fae0362b193132d5b54fa

Brand Name

Pantera

License Holder

Biotronik Medical Devices India Pvt Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

Orsiro Mission is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heartdisease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (Pantera) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets: • Acute Coronary Syndrome (Pantera) • ST-Elevation Myocardial Infarction (Pantera) • Diabetes Mellitus (Pantera) • Complex Lesions (Pantera) • High Bleeding Risk (Pantera) • Long Lesions (Pantera) (Pantera) • Small Vessels (Pantera) (Pantera) • Multi-Vessel Disease (Pantera) • Male/Female • Old Patients (Pantera)