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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 STENT ON RAPTORRAIL STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS027
Date Received03/21/2001
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 the elective indication as specified: 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 to 5. 0 mm.
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