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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 WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC CORPORATION
one scimed place
maple grove, MN 55311-1566
PMA NumberP980033
Supplement NumberS035
Date Received06/19/2013
Decision Date07/18/2013
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITIONAL VENDOR LOCATION TO SUPPLY MANUFACTURING AIDS AND COMPONENTS USED IN THE MANUFACTURING PROCESS OF THE DEVICES.
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