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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 SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
Applicant
BEST VASCULAR, INC
4350 international boulevard
norcross, GA 30093
PMA NumberP000018
Supplement NumberS024
Date Received09/03/2002
Decision Date09/30/2002
Product Code
MOU[ Registered Establishments with MOU ]
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 
CHANGE IN THE MANUFACTURING PROCESS OF THE NOVOSTE BETA-CATH SYSTEM SOURCE TRAIN GOLD MARKERS WHICH INVOLVES THE REMOVAL OF THE ELECTROLESS NICKEL FLASHING PROCESS.
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