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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.
 
Trade NameWALLSTENT ILIAC ENDOPROSTHESIS
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP940019
Supplement NumberS004
Date Received09/14/1998
Decision Date03/30/1999
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes related to mri claims.
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