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. |
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Device | ActaStim-S Non Invasive Spine Fusion Stimulator |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Theragen, Inc. 11220 Assett Loop Suite 101 Manassas, VA 20109 |
PMA Number | P190030 |
Supplement Number | S002 |
Date Received | 02/21/2023 |
Decision Date | 03/23/2023 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Distribute the device incorporating the alternative battery. |
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