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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 Blvd.
Norcross, GA 30093
PMA NumberP000018
Supplement NumberS051
Date Received05/05/2023
Decision Date09/26/2024
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a reduction in the existing minimum dose rate of the Jacketed Radiation Source Trains (JRST) of the Beta-Cath 3.5Fr System from 64.4 mGy/s to 58.5 mGy/s.
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