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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.
 
DeviceCMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)
Generic NameStimulator, bone growth, non-invasive
ApplicantDjo, LLC
1430 Decision St.
Vista, CA 92081-8553
PMA NumberP910066
Supplement NumberS031
Date Received10/23/2019
Decision Date01/23/2020
Product Code LOF 
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 design changes to the microcontroller and associated changes to the printed circuit board of the CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic).
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