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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 NameBX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS028
Date Received04/06/2001
Decision Date09/21/2001
Product Code
MAF[ Registered Establishments with MAF ]
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 a new indication (elective stenting of de novo and restenotic coronary arteries) and additional stent diameters (4. 5 and 5. 0 mm) for the bx velocity with hepacoat on stent 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 in length 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 in 4. 00 mm. The 2. 25 mm, 2. 50 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.
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