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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 (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameendoprosthesis with unistep plus delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP930031
Supplement NumberS023
Date Received12/20/2004
Decision Date01/14/2005
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
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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