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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceActaStim-S Spine Fusion Stimulator
Generic Namestimulator, bone growth, non-invasive
ApplicantTheragen, Inc.
11220 assett loop
suite 101
manassas, VA 20109
PMA NumberP190030
Date Received11/18/2019
Decision Date12/09/2020
Product Code LOF 
Docket Number 20M-2288
Notice Date 12/16/2020
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the ActaStim-S Spine Fusion Stimulator is a noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is Rx only, and intended for single patient use in adult patients only.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
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