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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(R) TIPS ENDOPROSTHESIS AND UNISTEP(TM) PLUS DELIVERY SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Namestent endoprosthesis
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP930031
Supplement NumberS007
Date Received09/01/1999
Decision Date05/04/2000
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a reduced profile unistep plus delivery system for 10 mm diameter stents.
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