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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.
 
DeviceMAGIC WALLSTENT ENDOPROSTHESIS SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
two scimed place
maple grove, MN 
PMA NumberP980009
Supplement NumberS012
Date Received02/03/2003
Decision Date02/26/2003
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 process to transfer several production steps to an alternate set of production equipment & re-ordering the manufacturing process sequence and eliminating duplicate inspection checks.
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