In Brief: ATS Medical
This article was originally published in The Gray Sheet
ATS Medical: Receives marketing approval for its Open Pivot mechanical heart valve in Japan, where sales are being handled by Century Medical, Inc. ATS submitted an investigational device exemption for the valve to FDA in October 1994 ("The Gray Sheet" March 6, 1995, p. 16) but has not initiated U.S. clinical trials due to agency requests for additional information on issues such as mechanical data, durability and in vitro testing. ATS says the valve has been implanted in approximately 10,000 subjects outside the U.S...
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