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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 PLACE
MAPLE GROVE, MN 
PMA NumberP980009
Supplement NumberS005
Date Received02/25/2000
Decision Date03/23/2000
Withdrawal Date 09/28/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the alternate sterilization facility located at Gammaster Ireland Ltd., Westport, County Mayo, Ireland.
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