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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 Spine Fusion Stimulator
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantTheragen, Inc.
11220 Assett Loop, Suite 101
Manassas, VA 20109
PMA NumberP190030
Supplement NumberS003
Date Received08/15/2024
Decision Date11/13/2024
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 minor changes to the device’s Instructions for Use to indicate that the device provides 270 days of continuous treatment, to revise the instructions to the user upon completion of treatment, and to indicate that the ActaStim-S system, excluding consumables, has an expected lifetime of three years.
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