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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 NameNIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS024
Date Received08/03/2000
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 nir(tm) elite monorail and otw stent systems. The devices are indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length <=25 mm) in reference vessel diameter of 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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