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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 NamePROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS003
Date Received10/02/1997
Decision Date11/18/1997
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes tot he precautions and clinical procedure sections of the instructions for use.
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