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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 NameRADIUS CORONARY STENT WITH DELIVERY SYSTEM
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP970061
Supplement NumberS008
Date Received01/24/2000
Decision Date02/11/2000
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the addition of two tensile strenght specifications for the pullwire assembly.
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