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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBETA-CATH SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBEST VASCULAR, INC
4350 INTERNATIONAL BOULEVARD
NORCROSS, GA 30093
PMA NumberP000018
Supplement NumberS043
Date Received11/28/2006
Decision Date11/19/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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