PMA P190030S004
- Device
- ActaStim-S
- Applicant
- Theragen, Inc.
- PMA number
- P190030
- Supplement
- S004
- Product code
- LOF
- Decision date
- 2026-05-13
- Classification
- Orthopedic
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for allowance for reconditioning of the ActaStim-S Spine Fusion Stimulator.
Current openFDA PMA Record#
- Device
- ActaStim-S
- Applicant
- Theragen, Inc.
- PMA number
- P190030
- Supplement
- S004
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2026-05-13
- Decision code
- APPR
- Date received
- 2024-12-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for allowance for reconditioning of the ActaStim-S Spine Fusion Stimulator.