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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(TM) BETA-CATH SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameb-cath delivery catheters
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS023
Date Received07/18/2002
Decision Date07/31/2002
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 to implement a new process of applying the o-rings to the proprietary connector using an o-ring installation tool.
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