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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.
 
DeviceSCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
Two Scimed Pl.
Maple Grove, MN 
PMA NumberP980009
Supplement NumberS011
Date Received03/08/2002
Decision Date04/12/2002
Withdrawal Date09/28/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO A PROCESS STEP IN WHICH THE MAGIC WALLSTENT DEVICE TIP IS INSERT-MOLDED ONTO THE INNER CATHETER SHAFT RATHER THAN ADHESIVELY ATTACHED.
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