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/2021/000295_d295000b0673217d6f1d6fb505e2c368_4fdd6d4400fa2a4bbbeeb93b701a3bbb. This device is marketed under the brand name Non-Sterile. The license holder is M/s Vascular Concepts Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Non-Sterile
License Holder
M/s Vascular Concepts Ltd.Device Class
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 (Non-Sterile) and is intended to improve coronary luminal diameter. Long term outcome for this permanent implant is unknown at present
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