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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 EXTRA SECURITY (ES) DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E.COUNTY RD. B EAST
ST PAUL, MN 55117
PMA NumberP920004
Supplement NumberS014
Date Received12/26/2000
Decision Date03/13/2001
Withdrawal Date 12/06/2013
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO MANUFACTURE THE VASOSEAL ES DEVICE AT A NEW FACILITY LOCATED AT DATASCOPE CORP. MAHWAH, NEW JERSEY.
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