PMA P190030S001
- Device
- ActaStim-S Spine Fusion Stimulator
- Applicant
- Theragen, Inc.
- PMA number
- P190030
- Supplement
- S001
- Product code
- LOF
- Decision date
- 2022-06-17
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for modifications to the device battery charger.
Current openFDA PMA Record#
- Device
- ActaStim-S Spine Fusion Stimulator
- Applicant
- Theragen, Inc.
- PMA number
- P190030
- Supplement
- S001
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2022-06-17
- Decision code
- APPR
- Date received
- 2022-04-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the device battery charger.