CDSCO UID MFG/MD/2020/000257_480c36db004746cd8625cbc9ff462bd9_fb76fc3d0ba29145d0151541470adf7c
Cobalt Chromium Coronary Stent System
Sahajanand Medical Technologies Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: 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
Registration details
- UID
- MFG/MD/2020/000257_480c36db004746cd8625cbc9ff462bd9_fb76fc3d0ba29145d0151541470adf7c
- Device class
- Class D
- 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.
- 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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About this record
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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