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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)
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP920004
Supplement NumberS004
Date Received10/22/1996
Decision Date12/02/1996
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGES TO THE INDICATIONS FOR USE TO INCLUDE USE OF VASOSEAL(R) FOLLOWING NON-CORONARY ANGIOGRAPHY AND NON-CORONARY BALLOON ANGIOPLASTY PROCEDURES
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