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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.
 
DeviceWALLSTENT (TIPS AND VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP930031
Supplement NumberS022
Date Received06/25/2004
Decision Date07/22/2004
Product Code MIR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REDUCTION IN BOND CURE TIMES FOR TWO PROCESSING STEPS USED IN THE MANUFACTURE OF THE STENT DELIVERY CATHETER FOR THE ABOVE-STATED DEVICES.
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