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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.
 
DeviceVASOSEAL (TM)
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E.COUNTY RD. B EAST
ST PAUL, MN 55117
PMA NumberP920004
Supplement NumberS001
Date Received01/16/1996
Decision Date08/01/1996
Withdrawal Date 12/06/2013
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A REDUCED TIME TO AMBULATION CLAIM TO THE INDICATIOS FOR USE
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