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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 Namestent, coronary
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980033
Supplement NumberS004
Date Received12/12/2002
Decision Date01/10/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change from a manual to an automatic cleaning and passivation process.
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