PTA – Sirolimus Eluting Catheter - India CDSCO Medical Device Registration
PTA – Sirolimus Eluting Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000435_f19bf33bb9d42f97d43c537759591c5a_65a807ebd299e223d05106b3f02ea7a0. 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 dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistula. This catheter is not intended for the expansion or delivery of stents
