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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.
 
DeviceTHORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular (assisst) bypass
Applicant
THORATEC LABORATORIES CORP.
2023 eighth st.
berkeley, CA 94710
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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