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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.
 
DeviceTHORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC CORP.
6035 stoneridge dr.
pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS035
Date Received04/16/2014
Decision Date05/06/2014
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a supplier for the sintering process for the heartmate ii lvas components.
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