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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 VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980033
Supplement NumberS006
Date Received03/12/2003
Decision Date04/01/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use (ifu) manual, namely a modification to the sizing requirements of the introducer sheaths and a modification to the description of the recommended guide wire to be used with the wallstent venous endoprosthesis with unistep plus delivery system.
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