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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 AT 6F SUTURE-MEDIATED CLOSURE SYSTEM & THE PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS071
Date Received04/07/2010
Decision Date05/05/2010
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate supplier for two overmolded components.
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