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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 ENDOPROTHESIS NATIVE CORONARY INDICATION
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
TWO SCIMED PLACE
MAPLE GROVE, MN 
PMA NumberP980009
Supplement NumberS001
Date Received10/30/1998
Decision Date01/27/1999
Withdrawal Date 09/28/2007
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for protocol for the post approval study.
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