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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWALLSTENT VENOUS ENDOPROSTHESIS
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311-1566
PMA NumberP980033
Supplement NumberS020
Date Received04/18/2012
Decision Date06/06/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
REMOVAL OF TWO IN-PROCESS CLEANING STEPS.
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