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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 SELF-EXPANDING CORONARY STENT
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
Two Scimed Pl.
Maple Grove, MN 
PMA NumberP980009
Supplement NumberS003
Date Received01/19/1999
Decision Date02/17/1999
Withdrawal Date09/28/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for change to the Instructions for Use.
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