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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 NameSCIMEN RADIUS STENT WITH MONORAIL DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP970061
Supplement NumberS014
Date Received01/08/2002
Decision Date02/15/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor labeling changes to the package labeling and the "directions for use" manual for the radius coronary stent system. The device, as modified, will be marketed under the trade name scimed radius stent with monorail delivery system and is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length < 30 mm) with a reference vessel diameter ranging from 2. 75 to 4. 25 mm and is intended to improve coronary luminal diameter.
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