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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
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP970061
Supplement NumberS004
Date Received09/04/1998
Decision Date09/25/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the instructions for use.
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