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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 IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS039
Date Received12/27/2007
Decision Date01/31/2008
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise the ivad instructions for use to delete the reference to paracorporeal placement of the ivad and indicate that the ivad should be contraindicated for the paracorporeal placement.
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