Altius® Direct Electrical Nerve Stimulation System
FDA premarket approval P230020/S005 · decided 2025-12-03
Approval details
- PMA number
- P230020
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2025-07-07
- Decision date
- 2025-12-03
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- SAZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- approval for a manufacturing site located at Neuros Medical, Inc., 1212 Red Fox Road, Arden Hills, Minnesota, 55112. The main manufacturing operations performed at this facility include, but are not limited to, the receipt of sterile and non-sterile finished packaged devices ready for distribution from two contract manufacturing organization facilities, evaluation of returned devices, calibration and maintenance of inspection equipment, and serve as the specification developer and design control
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