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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
The Australian Medical Device Vigilance System
1Therapeutic Devices Branch, Therapeutic Goods Administration, Woden, Australia.
Studies in Health Technology and Informatics
|December 9, 1995
Abstract:
Since its inception, in 1986, the Australian Vigilance System has had voluntary and compulsory components. The voluntary component is the Therapeutic Device Problem Reporting Scheme and the compulsory one is requirements on sponsors to report as a condition of entry on the Australian Register of Therapeutic Goods. In addition, reports produced worldwide are actively monitored for their applicability to Australia.
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