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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 NameNIROYAL(TM) ELITE OVER-THE-WIRE(OTW) STENT SYSTEM
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS022
Date Received07/13/2000
Decision Date02/16/2001
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 the niroyal(tm) elite otw stent system. The device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (lenth <=25 mm) in reference vessel diameter 3. 0 to 4. 0 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2. 5 to 4. 0 mm; and 3) patients with symptomatic heart disease due to lesions in saphenous vein bypass grafts with lesion length <=30 mm and reference diameter in the range of 3. 0 to 4. 0 mm.
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