Altius® Direct Electrical Nerve Stimulation System
FDA premarket approval P230020/S001 · decided 2024-12-19
Approval details
- PMA number
- P230020
- Supplement
- S001
- 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
- 2024-11-25
- Decision date
- 2024-12-19
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- SAZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- the replacement of a sub-component of EPO-TEK® 301 epoxy, known as Part A, with an equivalent material sourced from a different supplier
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.