Saluda Medical Evoke SCS System
FDA premarket approval P190002/S012 · decided 2023-05-05
Approval details
- PMA number
- P190002
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Saluda Medical Evoke SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Saluda Medical Pty, Ltd.
- Date received
- 2022-05-16
- Decision date
- 2023-05-05
- Days to decision
- 354 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for changes which include:1) Modification of the implanted pulse generator (IPG) without changes to delivered therapy;2) Modification of the external Closed-Loop Stimulator (eCLS) to be consistent with the new IPG features and to replace obsolete components;3) Firmware and Software changes to: a. Simplify use of Clinical Software, b. Improve usability and user interface during programming, and c. Improve traceability.4) Change from Surface Pro 4 to Surface Pro 6 as hardware platform for
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