Medical Devices
Thoratec completes PMA for bridge-to-transplantation use of left ventricular assist device
Published in Medical Letter on the CDC and FDA, January 28th, 2007
On October 31, 2006, Thoratec announced that it had filed the first two modules of the PMA that addressed all of the supporting engineering and preclinical studies, as well as manufacturing and quality systems. At that time, the company indicated that it would file the clinical module once the necessary number of patients reached the efficacy endpoint and...
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