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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(TM) SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBEST VASCULAR, INC
4350 INTERNATIONAL BOULEVARD
NORCROSS, GA 30093
PMA NumberP000018
Supplement NumberS003
Date Received12/19/2000
Decision Date04/24/2001
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BETA-CATH(TM) SYSTEM. THE POST-APPROVAL STUDY IS INTENDED TO VERIFY THAT THE CORRECTIVE ACTIONS, INTENDED TO HELP MINIMIZE THE INCIDENCE OF DEVICE FAILURES AND MALFUNCTIONS SEEN DURING THE PREMARKET CLINICAL INVESTIGATION, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE.
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