Ann: Appendix 4C - quarterly, page-174

Page 8 of the linked document;

"Dr Alphonso independently made a notification to the TGA on 19 April 2017.
Dr Alphonso liaised with the manufacturer, Amedus Regen Ltd, including a
visit to the Admedus facility in Perth on 16 May 2017. During this visit he
received a demonstration of their quality assurance & control processes for
CardioCel including a tour through the facility which lasted several hours. The
technology and methods were explained to him by the inventor of CardioCel,
Prof WML Neethling. Dr Alphonso also reviewed the batch release records
for the two CardioCel patches that were implanted in Joshie. He
subsequently advised the TGA he had no concerns about the testing
processes and the structural integrity of CardioCel and indicated his continued
use of it in his practice for the repair of congenital heart defects.
The CardioCel device is FDA approved and CE certified and commercially
available in the USA, European Union and Canada. It is also registered and
commercially available in Singapore, Malaysia, Hong Kong and several
Middle East countries.
The manufacturer advised that over 8700 CardioCel patches have been
implanted worldwide with no device-related adverse events in terms of
structural integrity or sterility having been reported or questioned."