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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 (VAD) ASSIST DEVICE SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC LABORATORIES CORP.
PMA NumberP870072
Supplement NumberS010
Date Received04/11/2000
Decision Date11/15/2000
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a surgical implant accessory kit with the following accessories: ventricular cannula venting connector, valve housing caps, cannula plugs, atrial cannula tip cap, and y-connector cap. The accessory kit will be manufactured at horizon medical, inc. , santa ana, california, and sterilized by sterigenics, tustin, california.
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