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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 NameSTARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular closure system
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP050007
Supplement NumberS006
Date Received05/07/2007
Decision Date07/30/2007
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the pusher body for both the starclose? vascular closure system (vcs) and the starclose? se vascular closure system ad for the addition of chambers on the interior of the starclose? se vascular closure system to improve the retraction of the thumb advancer.
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