Cobalt Chromium Coronary Stent System - India CDSCO Medical Device Registration

Cobalt Chromium Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000257_480c36db004746cd8625cbc9ff462bd9_fb76fc3d0ba29145d0151541470adf7c. This device is marketed under the brand name 1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr. The license holder is Sahajanand Medical Technologies Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Cobalt Chromium Coronary Stent System

UID: MFG/MD/2020/000257_480c36db004746cd8625cbc9ff462bd9_fb76fc3d0ba29145d0151541470adf7c

Brand Name

1.Supraflex, 2. Flexilimus, 3. Protolimus, 4. Vactaflex, 5. Supralimus-Flex, 6. Flexilimus Plus, 7. Protolimus Plus, 8. Vactaflex Plus, 9. Supralimus Flex Plus, 10. Aima Plus, 11. Abrax CoCr

License Holder

Sahajanand Medical Technologies Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Coronary Stent System are indicated for improving coronary luminal diameter in the following: a. Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions with reference vessel diameters ranging from 2.0 mm to 4.5 mm. b. Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with reference vessel diameters ranging from 2.0 mm to 4.5 mm. c. Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions with a reference vessel diameter of 2.0 mm to 4.5 mm

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Cobalt Chromium Coronary Stent System

Brand: 3V SIRIS

S3V VASCULAR TECHNOLOGIES LIMITED

Cobalt Chromium Coronary Stent System - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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Cobalt Chromium Coronary Stent System

Cobalt Chromium Coronary Stent System

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