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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.
 
DeviceSUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS043
Date Received11/18/2002
Decision Date12/20/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE SUTURE TRIMMER (ST). SPECIFICALLY THE ST WAS MODIFIED TO OPERATE BY SLIDING RATHER THAN BY CLEAVING THE SUTURE BY CUTTING SURFACE ROTATION.
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