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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 IMPLANTABLE VENTRICULAR ASSIST DEVICE
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS040
Date Received04/21/2008
Decision Date10/31/2008
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to strengthen the ivad y-connector termination by adding a small amount (35 ul) of silicone oil to the inner wall of the pneumatic line to reduce the transferable force between the ivad optical sensor cable and the pneumatic line wall.
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