Gelita-Spon ENT Sponge (Absorbable Gelatin Sponge) - Gelatin haemostatic agent
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
16-11-2017
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Available from:
Life Healthcare Pty Ltd
Class:
Class III
Manufactured by:
Gelita Medical GmbH Uferstrasse 7, Eberbach, 69412 Germany
Therapeutic area:
48170 - Gelatin haemostatic agent
Therapeutic indications:
Following application of sponge to surface of defect or insertion into the surgically created void, the sponge results in rapid haemostasis by concentrating blood platelets and coagulating factors released by surgically/trauma-induced venous or diffuse oozing haemorrhage within the gelatin matrix. To achieve local haemostasis by tamponade effect; to support and separate tissues to prevent adhesions, e.g.keep the fascia or perichondrium in place following tympanoplasty.
Authorization status:
A
Authorization date:
2008-09-16
