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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
3200 lakeside drive
santa clara, CA 95054
PMA NumberP050007
Supplement NumberS015
Date Received06/30/2009
Decision Date11/13/2009
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change two manually performed operations to semi-automated operations and the removal of an in-process inspection.
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