Endometrial-ablation hyperthermia catheter
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
04-11-2017
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Available from:
GRC Surgical Pty Ltd
Class:
Class IIb
Manufactured by:
Lina Medical APS Formervagen 5, GLOSTRUP, 2600 Denmark
Therapeutic area:
58864 - Endometrial-ablation hyperthermia catheter
Therapeutic indications:
A thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Authorization status:
A
Authorization date:
2016-10-06
