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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.
 
DeviceSUTURE MEDIATED CLOSURE (SMC) SYSTEMS
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS064
Date Received08/15/2008
Decision Date09/12/2008
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 
MODIFICATION TO THE STERILIZATION CYCLE FOR THE DEVICE.
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