Coronary angioplasty balloon catheter, drug-eluting
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-04-2022
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Available from:
Medtronic Australasia Pty Ltd
Class:
Class I
Manufactured by:
Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America
Therapeutic area:
62218 - Coronary angioplasty balloon catheter, drug-eluting
Therapeutic indications:
The Prevail paclitaxel-coated PTCA balloon catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.0 mm to 4.0 mm to treat de novo lesions, in-stent restenosis (ISR), and small vessel disease (SVD).
Authorization status:
A
Authorization date:
2022-02-01
