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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceKNOT PUSHER WITH TRIMMER(TM)
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
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/material
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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