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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 (ILIAC, TIPS, 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 NumberS012
Date Received12/20/2004
Decision Date01/14/2005
Product Code QKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS.
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