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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 & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
Generic Namefemoral artery closure system
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS018
Date Received04/22/1999
Decision Date05/26/1999
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an additional package label identifying the sterile barrier.
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