Preformed vocal cord medialization implant
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
20-07-2023
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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIb
Manufactured by:
APrevent Biotech GmbH The Icon Vienna, Tower 24 3rd Floor, Wiedner Gurtel 13, Vienna, 1100 Austria
Therapeutic area:
46942 - Preformed vocal cord medialization implant
Therapeutic indications:
The implants are intended to be used for Type I Thyroplasty operations in patients with unilateral vocal fold paralysis (UVFP) /glottic insufficiency to improve voice quality.
Authorization status:
A
Authorization date:
2022-11-16
