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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.
Generic Namecatheter
PMA NumberP980001
Supplement NumberS023
Date Received08/03/2000
Decision Date01/25/2001
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 additional stent lengths (i. E. , 9 mm, 12 mm and 18 mm) for the niroyal(tm) elite premounted stent system. The device is indicated for improving coronary luminal diameter in the following: 1) patients with synptomatic 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 synptomatic 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.