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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 VENTRICULAR ASSIST DEVICE SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS034
Date Received07/13/2006
Decision Date06/28/2007
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a material change in the tubing that connects the body of the paracorporeal thoratec ventricular assist device with the metal y-connector that splits the line into separate electrical and pneumatic connections.
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