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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 NumberS001
Date Received08/10/1998
Decision Date02/04/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification ot the indications statement to include the treatment of saphenous vein graft lesions. The scimed radius(tm) coronary stent (14 mm and 20 mm lengths) with delivery system is indicated for use in patients with symptomaitc ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diamter ranging from 2. 75 to 4. 25 mm and is intended to improve coronary luminial diameter.
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