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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.
 
DeviceWALLSTENT(R) TIPS ENDOPROSTHESIS AND UNISTEP(TM) PLUS DELIVERY SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, portosystemic, endoprosthesis
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
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/material
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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