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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 SUTURE MEDIATED CLOSURE DEVICE, PERCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS084
Date Received08/26/2013
Decision Date09/25/2013
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 
Removing a redundant inspection for bleedback lumen patency from the manufacturing process.
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