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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.
 
DeviceBX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP900043
Supplement NumberS040
Date Received05/21/2002
Decision Date05/31/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification in the stent crimping process.
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