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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/WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS033
Date Received02/01/2002
Decision Date03/05/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two changes to the quality plan for the products.
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