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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.
 
DeviceNOVOSTE BETA-CATH SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBEST VASCULAR, INC
4350 INTERNATIONAL BOULEVARD
NORCROSS, GA 30093
PMA NumberP000018
Supplement NumberS016
Date Received08/07/2001
Decision Date01/30/2002
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE 30 MM AND 40 MM BET SYSTEMS. THE REVISED 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 INVESTIGATIONS, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE.
Post-Approval StudyShow Report Schedule and Study Progress
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