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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.
 
DeviceMAGIC WALLSTENT ENDOPROSTHESIS SYSTEM
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
Two Scimed Pl.
Maple Grove, MN 
PMA NumberP980009
Supplement NumberS012
Date Received02/03/2003
Decision Date02/26/2003
Withdrawal Date09/28/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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