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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.
 
DeviceORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantDjo, LLC
1430 Decision St.
Vista, CA 92081
PMA NumberP910066
Supplement NumberS009
Date Received07/06/1998
Decision Date07/14/1998
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for marketing circular.
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