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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 CORPORATION
PMA NumberP980033
Supplement NumberS025
Date Received09/28/2012
Decision Date10/24/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the aeration cycle time for an ethylene oxide sterilization cycle.
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