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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
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR DEVICES
400 saginaw dr.
redwood city, CA 94063
PMA NumberP050007
Supplement NumberS019
Date Received08/04/2009
Decision Date09/01/2009
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the subassembly bonding process.
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