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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 SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM
Generic Nameintravascular stent with delivery system
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP970061
Supplement NumberS005
Date Received09/08/1998
Decision Date02/11/1999
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a single-operator exchange (soe) delivery system for the scimed(r) radius(tm) stent. The device, as modified, will be marketed under the trade name scimed(r) radus(tm) coronary stent with single-operator exchange (soe) delivery system and is indicated for use in pateitns with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diameter ranging from 2. 75 to 4. 25mm and is intended to improve coronary luminal diameter.
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