NOTE: This report has been prepared to provide rapid advice of the Resolutions of the Advisory Committee on Medical Devices (ACMD) at its recent meeting. It should not be assumed that advice given to the TGA represents the decisions of the TGA.
The 2012/1 meeting of the ACMD was held on 16 March 2012. The recommendation listed below was supported by the ACMD.
ACMD 2012/1 meeting resolutions
Johnson & Johnson Medical Pty Ltd – PROMOGRAN Protease Modulating Matrix, PROMOGRAN PRISMA Wound Balancing Matrix
Resolution: 2012/2
ACMD advice:
ACMD agrees with the clinical, sterility and biocompatibility assessors that the evidence demonstrates compliance with the relevant essential principles for safety, quality and performance.