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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 NameNOVOSTE BETA-CATH SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameb-cath delivery catheters
ApplicantNOVOSTE CORP.
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: manufacturing
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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