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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.
 
DeviceANGIO-SEAL VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
St. Jude Medical, Inc.
6500 wedgwood rd.
maple grove, MN 55330
PMA NumberP930038
Supplement NumberS067
Date Received07/05/2011
Decision Date04/15/2013
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at st. Jude medical, inc. , in minnetonka, minnesota.
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