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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(TM) BETA-CATH(TM) SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBest Vascular, Inc.
4350 International Blvd.
Norcross, GA 30093
PMA NumberP000018
Supplement NumberS019
Date Received10/02/2001
Decision Date05/02/2002
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE NOVOSTE BETA-CATH XL DELIVERY CATHETER (TOTAL LENGTH 267 CM.) TO BE USED WITH THE 30 AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
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