PMA P230020S011

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S011
Product code: SAZ
Decision date: 2026-10-16
Classification: Neurology
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Approval order statement: outsourcing insulator die-cutting activities and updating the associated dimensional tolerances

Current openFDA PMA Record#

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S011
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2026-10-16
Decision code: OK30
Date received: 2026-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: outsourcing insulator die-cutting activities and updating the associated dimensional tolerances