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Coronary Stent System- Stainless Steel Balloon Expandable (Prolink LP - Coronary Stent System- Stainless Steel Balloon Expandable ) - India CDSCO Medical Device Registration

Coronary Stent System- Stainless Steel Balloon Expandable (Prolink LP - Coronary Stent System- Stainless Steel Balloon Expandable ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000521_d295000b0673217d6f1d6fb505e2c368_3b075f9e77ad534d478524c90ac6260d. This device is marketed under the brand name Cobalt Chromium. The license holder is Vascular Concepts Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Coronary Stent System- Stainless Steel Balloon Expandable (Prolink LP - Coronary Stent System- Stainless Steel Balloon Expandable )
UID: IMP/MD/2019/000521_d295000b0673217d6f1d6fb505e2c368_3b075f9e77ad534d478524c90ac6260d

Brand Name

Cobalt Chromium

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Prolink LP Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete coronary de novo artery lesions with a reference vessel diameter ranging from 2.0mm to 4.5mm (Cobalt Chromium) and is intended to improve coronary luminal diameter. Long term outcome for this permanent implant is unknown at present

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