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Sirolimus Eluting Coronary Stent System(Trackflex & Stenoflex ) - India CDSCO Medical Device Registration

Sirolimus Eluting Coronary Stent System(Trackflex & Stenoflex ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000057_d7f571f83378f6e338792592e6010ce6_aa6e0f166fd7953f14e789a5c81ee57c. This device is marketed under the brand name TM under process. The license holder is KAMAL ENCON INDUSTRIES LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.

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CDSCO Registered
Class Class D
Sirolimus Eluting Coronary Stent System(Trackflex & Stenoflex )
UID: MFG/MD/2019/000057_d7f571f83378f6e338792592e6010ce6_aa6e0f166fd7953f14e789a5c81ee57c

Brand Name

TM under process

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

Sirolimus Eluting Coronary Stent System is intended for use in the patient eligible for Percutaneous Transluminal Coronary Angioplasty (TM under process). Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length 40 mm in native coronary arteries with a reference vessel diameter of 2.00 to 4.50 mm and those who are eligible for Percutaneous Transluminal Coronary Angioplasty (TM under process)

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