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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 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantTHORATEC CORP.
PMA NumberP060040
Supplement NumberS024
Date Received08/08/2012
Decision Date10/05/2012
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the shelf-life of both the heartmate ii (hm ii) sealed outflow graft and the sealed inflow conduit from the current labeling of three years to five years.
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