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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.
 
DeviceWALLSTENT (TIPS AND 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 NumberS010
Date Received04/09/2004
Decision Date05/07/2004
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 
Change in the manufacturing material used in the manufacture of the exterior tube for the device.
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