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CDSCO UID IMP/MD/2020/000435_1211342e479090d535c6f7abc4ca747c_da544dba076adc324919545443f6dbec

PTCA – Sirolimus Eluting Catheter

Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India·Device Class Class C·India CDSCO·Brand: ALEX PTA
Registration details
UID
IMP/MD/2020/000435_1211342e479090d535c6f7abc4ca747c_da544dba076adc324919545443f6dbec
Device class
Class C
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 ,India
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.
Similar products (1)
Other products with the same name or brand
PTA – Sirolimus Eluting Catheter
Brand: ALEX PTA
Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India
Class C
Other products from Heartwave Medical Private Limited ,C-67, THIRD FLOOR, DDA SHEDS, OKHLA INDUSTRIAL AREA PHASE-I ,New Delhi Delhi ,110020 ,India
Products from the same license holder (2 products)
PTA – Sirolimus Eluting Catheter
Brand: ALEX PTA
Class C
L605 Sirolimus Eluting Stent
Brand: Cobalt Chromium
Class D
About this record

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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