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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameWALLSTENT(R) ILIAC ENDOPROSTHESIS
Classification Namestent, iliac
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP940019
Date Received06/09/1994
Decision Date05/28/1996
Product Code
NIO[ Registered Establishments with NIO ]
Docket Number 97M-0054
Notice Date 02/21/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 6 mm through 10 mm diameter wallstent iliac endoprosthesis.
Supplements: S002 S003 S004 S005 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 
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