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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
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS027
Date Received10/21/2002
Decision Date10/23/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change an electronic data management system, referred to as the betacal system.
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