ActaStim-S Spine Fusion Stimulator
FDA premarket approval P190030/S001 · decided 2022-06-17
Approval details
- PMA number
- P190030
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ActaStim-S Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Theragen, Inc.
- Date received
- 2022-04-08
- Decision date
- 2022-06-17
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Manassas, VA
- Statement
- Approval for modifications to the device battery charger.
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