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Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Implant - Pouch, Medtronic Australasia Pty Ltd, CON-1054
Product name
Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Implant - Pouch
Sponsor name
Medtronic Australasia Pty Ltd
Consent start
Consent no.
CON-1054
Duration
The consent is effective from 16 December 2022 until 21 June 2023.
Standard
clause 11(18) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products do not conform with clause 11(18) of TGO 108 that specifies that
the serum or plasma of a blood sample taken from a donor of HCT materials must
be retained for a minimum of two years after the expiry date of the relevant HCT
product, or for a period that is validated on the basis of validated data or
documented evidence from relevant scientific literature.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines