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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 6FR SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP960043
Supplement NumberS053
Date Received03/15/2004
Decision Date04/22/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised instructions for use, intended to enhance the safe use of the device.
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