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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.
 
DeviceEXOGEN 2000+ AND EXOGEN 3000
Generic NameStimulator, ultrasound and muscle, for use other than applying therapeutic deep
Regulation Number890.5870
ApplicantBioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703
PMA NumberP900009
Supplement NumberS018
Date Received01/29/2004
Decision Date03/12/2004
Reclassified Date05/18/2026
Product Code LPQ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TWO DESIGN AND COMPONENT CHANGES: 1) CHANGES TO EXOGEN 2000+ PRINTED CIRCUIT BOARD TO IMPLEMENT CORRECTIVE ACTION FOR FIELD FAILURE AND RETURNS. THIS CORRECTIVE ACTION INVOLVES TWO DESIGN CHANGES: I) REPLACE 2 DIODES ON TE PRINTED CIRCUIT BOARD WITH LIGHT EMITTING DIODES. II) ADD A 1000 PF CAPACITOR TO REDUCE ELECTRICAL NOISE. 2) REPLACE BOTH EXOGEN 2000+ AND EXOGEN 3000 TRANSDUCER CABLES WITH A MORE COST EFFECTIVE MODEL.
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