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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMAGIC WALLSTENT ENDOPROTHESIS NATIVE CORONARY INDICATION
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
two scimed place
maple grove, MN 
PMA NumberP980009
Supplement NumberS001
Date Received10/30/1998
Decision Date01/27/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for protocol for the post approval study.
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