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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.
 
DeviceActaStim-S
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantTheragen, Inc.
11220 Assett Loop, Suite 101
Manassas, VA 20109
PMA NumberP190030
Supplement NumberS004
Date Received12/30/2024
Decision Date05/13/2026
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
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 allowance for reconditioning of the ActaStim-S Spine Fusion Stimulator.
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