ActaStim-S Spine Fusion Stimulator
FDA premarket approval P190030/S003 · decided 2024-11-13
Approval details
- PMA number
- P190030
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ActaStim-S Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Theragen, Inc.
- Date received
- 2024-08-15
- Decision date
- 2024-11-13
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Manassas, VA
- Statement
- Approval for minor changes to the devices Instructions for Use to indicate that the device provides 270 days of continuous treatment, to revise the instructions to the user upon completion of treatment, and to indicate that the ActaStim-S system, excluding consumables, has an expected lifetime of three years.
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