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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVASOSEAL (TM)
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E.COUNTY RD. B EAST
ST PAUL, MN 55117
PMA NumberP920004
Date Received02/03/1992
Decision Date09/29/1995
Withdrawal Date12/06/2013
Product Code MGB 
Docket Number 95m-0394
Notice Date 12/15/1995
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VASOSEAL VASCULAR HEMOSTASIS DEVICE (VHD) IN ADDITION TO INDICATION ALREADY MENTIONED ALSO INDICATED FOR USE IN PTCA PATIENTS WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 
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