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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 NameBETA-CATH(TM)SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular brachytherapy system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS007
Date Received01/18/2001
Decision Date02/13/2001
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 supplier and the manufacturing method used in forming the proprietary connector of the beta-cath(tm) delivery catheter, from a machined to a molded process.
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