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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 RADIUS CORONARY STENT WITH DELIVERY SYSTEM
Generic Nameintravascular stent with delivery system
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP970061
Supplement NumberS003
Date Received08/19/1998
Decision Date09/15/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at scimed life systems, one scimed place, maple grove, minnesota.
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