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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 NameKNOT PUSHER WITH TRIMMER(TM)
Generic Namefemoral artery closure system
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS027
Date Received09/13/2000
Decision Date10/17/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for the knot pusher with trimmer, an accessory to the closer 6 fr. Smc system and the closer s 6 fr. Smc system.
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