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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC LABORATORIES CORP.
PMA NumberP870072
Supplement NumberS007
Date Received07/13/1998
Decision Date07/20/1998
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requested change in the supplier of the valves used to control the direction of blood flow in the ventricular assist device. The supplier will be changed from sorin biomedical in irvine, california to arrow international in reading pennsylvania.
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