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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 (TIPS, ILIAC, 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 NumberS016
Date Received12/18/2002
Decision Date01/17/2003
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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