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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 SYSTEM
Classification Nameintravascular radiation delivery system
ApplicantBEST VASCULAR, INC
PMA NumberP000018
Supplement NumberS042
Date Received03/09/2006
Decision Date06/16/2006
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the beta-cath system labeling, specifically the incorporation of the start/start 40/20 5-year post-approval study results in the beta-cath instructions for use.
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