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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 NumberS002
Date Received08/13/1998
Decision Date04/21/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Proposal for 5 year post-approval study protocol.
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