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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,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Generic NameStent, central venous
ApplicantBOSTON SCIENTIFIC CORPORATION
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP980033
Supplement NumberS005
Date Received12/18/2002
Decision Date01/17/2003
Product Code QKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS OF THE WALLSTENT DELIVERY SYSTEM WHICH INVOLVES THE REPLACEMENT OF THE CATHETER HUB BOND TO STAINLESS STEEL TUBE BOND CURE TIME WITH A REDUCED SET TIME.
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