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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
ApplicantBEST VASCULAR, INC
PMA NumberP000018
Supplement NumberS045
Date Received06/20/2011
Decision Date11/04/2011
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing lubing suppliers.
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