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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTAR CLOSE AND STAR CLOSE SE VASCULAR CLOSURE SYSTEMS
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR DEVICES
3200 lakeside drive
santa clara, CA 95054
PMA NumberP050007
Supplement NumberS024
Date Received02/23/2010
Decision Date04/22/2010
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE POUCH DESIGN AND PACKAGING METHODS.
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