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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.
 
Trade NameSCIMED MAGIC WALLSTENT ENDOPROSTHESIS WITH DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980009
Supplement NumberS011
Date Received03/08/2002
Decision Date04/12/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
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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