ActaStim-S Non Invasive Spine Fusion Stimulator
FDA premarket approval P190030/S002 · decided 2023-03-23
Approval details
- PMA number
- P190030
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ActaStim-S Non Invasive Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Theragen, Inc.
- Date received
- 2023-02-21
- Decision date
- 2023-03-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Manassas, VA
- Statement
- Distribute the device incorporating the alternative battery.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.