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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBX VELOCITY WITH HEPACOAT ON RAPTOR STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP900043
Supplement NumberS037
Date Received02/25/2002
Decision Date08/22/2002
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 TO AMEND THE LABELING (INSTRUCTIONS FOR USE) FOR THE DEVICES.
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