L605 Sirolimus Eluting Stent - India CDSCO Medical Device Registration
L605 Sirolimus Eluting Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000435_8f9cb33f5dc5b712330424093ef4514c_55262dab661061eb8660275d213bc8b5. This device is marketed under the brand name Cobalt Chromium. The license holder is Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Cobalt Chromium
License Holder
Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,IndiaDevice Class
Approving Authority
CDSCO
Product Information
intended for improving luminal diameter for the treatment of de novo lesions 42mm in length in native coronary arteries > 2.5 to 4.0 mm in diameter. The summary of the indications are: • De Novo (Cobalt Chromium) • Restenosis after PTCA • Vein bypass stenosis or closure • High risk of restenosis after PTCA • Dissection after PTCA • Recoil after PTCA • Acute vascular occlusion • Sub-optimal result after PTCA • The treatment of stenoses in lesions with branch arteries
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