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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.
 
DeviceNOVOSTE BETA-CATH 3.5F SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBest Vascular, Inc.
4350 International Blvd.
Norcross, GA 30093
PMA NumberP000018
Supplement NumberS040
Date Received12/16/2003
Decision Date06/10/2004
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE BETA-RAIL 3.5F DELIVERY CATHETER WITH DISTAL IMPROVEMENTS, AND A CHANGE IN THE PROCEDURE ACCESSORY PACK.
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