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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.
Classification Namestent, coronary
Generic Namestent, coronary
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP900043
Supplement NumberS025
Date Received07/10/2000
Decision Date02/02/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new indication (i. E. , de novo and restenotic lesions) and additional stent diameters (i. E. , 4. 5 and 5. 0 mm) for the bx velocity(tm) stent with raptor(tm) over-the-wire delivery system. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (<=30 mm inlength) in native coronary arteries with reference diameters ranging from 3. 0 mm to 5. 0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<=30 mm in length) with reference diameters in the range of 2. 25 mm to 4. 00 mm. The 2. 25 mm, 2. 5 mm, and 2. 75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4. 5 and 5. 0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.