PTCA – Sirolimus Eluting Catheter - India CDSCO Medical Device Registration
PTCA – Sirolimus Eluting Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000435_1211342e479090d535c6f7abc4ca747c_da544dba076adc324919545443f6dbec. This device is marketed under the brand name ALEX PTA. 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 C. The approving authority is CDSCO.
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Brand Name
ALEX PTA
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 use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions with a reference vessel diameter ranging from 1.5 mm to 4.0 mm and is intended to improve coronary luminal diameter.
