Paclitaxel Drug Coated PTA Balloon() - India CDSCO Medical Device Registration

Paclitaxel Drug Coated PTA Balloon() is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000257_7d4111768735b600b6f8e9422864d92e_7445fbbfb2a8108822d9cc41d9081894. 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

Paclitaxel Drug Coated PTA Balloon()

UID: MFG/MD/2020/000257_7d4111768735b600b6f8e9422864d92e_7445fbbfb2a8108822d9cc41d9081894

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 Paclitaxel drug coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 200 mm in length in native infrapopliteal arteries and popliteal arteries (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) with reference vessel diameters of 2-12 mm

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Everolimus Eluting Cobalt Chromium Coronary Stent System ()

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

Sahajanand Medical Technologies Pvt. Ltd.

Paclitaxel Drug Coated PTA Balloon() - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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Peripherics - Paclitaxel Drug Coated PTA Balloon