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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 NameTECHSTAR/PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS012
Date Received10/19/1998
Decision Date02/19/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at perclose, inc. , 400 saginaw dr. , redwood city, ca.
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