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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.
 
DevicePHYSIO-STIM BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantOrthofix, Inc.
3451 Plano Pkwy.
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS022
Date Received06/24/1998
Decision Date08/13/1998
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 a modification to the definition of non-union in the labeling (i.e., a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).
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