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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 VASCULAR CLOSURE SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR DEVICES
3200 lakeside drive
santa clara, CA 95054
PMA NumberP050007
Supplement NumberS008
Date Received12/20/2007
Decision Date01/17/2008
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 
Alternate method of manufacturing of the starclose clip used in the starclose and starclose se systems.
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