Saluda Medical Evoke SCS System
FDA premarket approval P190002/S010 · decided 2022-08-03
Approval details
- PMA number
- P190002
- Supplement
- S010
- Supplement type
- Real-Time Process
- 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
- 2022-05-09
- Decision date
- 2022-08-03
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Atarmon
- Statement
- Approval for modifications to software and firmware intended to reduce programming time in patients with significant evoked compound action potential (ECAP) artifact or negative ECAP values by adding the ClearCAP feature as well as minor labeling changes which include providing appropriate instructions for the new ClearCAP feature, updating the Evoke Pocket Console (EPC) product name to Evoke Patient Controller, and labelling updates required for commercialization.
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