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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 NamePERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP960043
Supplement NumberS052
Date Received02/20/2004
Decision Date03/18/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing to a new suture vendor (surgipro ii monofilament polypropylene suture. ).
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