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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 recommendations made to the TGA represent the decisions of the TGA.
The 2010/3 meeting of the ACMD was held on 10 September 2010. ACMD resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.
2010/3 meeting report and resolutions
Product: SeQuent Please
B Braun Australia Pty Ltd
- an application by B Braun Australia Pty Ltd for the provision of a conformity assessment certificate for SeQuent Please PTCA catheter with a drug coating on the balloon intended for use for all common coronary lesions including the following 'worse-case' indications:
- in patients with ISR (e.g. instead of a conventional uncoated PTCA catheter) and
- to treat small vessel disease (SVD).
Product: OSTEOSET T
Wright Medical Australia Pty Ltd
- an application by Wright Medical Australia Pty Ltd for the provision of a conformity assessment certificate for OSTEOSET T pellets intended to be gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defect or osseous defects created from traumatic injury to the bone. OSTEOSET pellets provide bone filler that resorbs and is replaced with bone during the healing process.