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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceActaStim-S Spine Fusion Stimulator
Generic Namestimulator, bone growth, non-invasive
Theragen, 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 Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling