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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 NumberS041
Date Received06/28/2004
Decision Date10/04/2004
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located in norcross, georgia, to process radiation source trains for the beta-cath system.
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