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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.
 
DeviceSTARCLOSE SE VASCULAR CLOSURE SYSTEM IFU
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR DEVICES
400 saginaw dr.
redwood city, CA 94063
PMA NumberP050007
Supplement NumberS028
Date Received02/22/2011
Decision Date03/24/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add adjunctive compression language to the labeling and instructions for use.
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