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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(VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Namenentricular assist device
ApplicantTHORATEC LABORATORIES CORP.
PMA NumberP870072
Supplement NumberS009
Date Received11/17/1998
Decision Date03/19/1999
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to move manufacturing facility located at thoratec lab, 2023 eighth st. , berkeley, ca, to thoratec lab, 6035 stoneridge dr. , pleasanton, ca.
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