Altius® Direct Electrical Nerve Stimulation System
FDA premarket approval P230020/S004 · decided 2025-06-05
Approval details
- PMA number
- P230020
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Altius® Direct Electrical Nerve Stimulation System
- Generic name
- stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
- Applicant
- Neuros Medical, Inc.
- Date received
- 2025-05-09
- Decision date
- 2025-06-05
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- SAZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- changes in the ethylene oxide (EO) sterilization cycle parameters, including optimization of EO concentration, for the Nerve Cuff Electrode of the Altius System
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