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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 XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM
Generic Namefemoral artery closure system
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS016
Date Received01/08/1999
Decision Date05/28/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the instructions for use to include an alternative surgical knot.
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