PMA P230020S004

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S004
Product code: SAZ
Decision date: 2025-06-05
Classification: Neurology
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Approval order statement: changes in the ethylene oxide (EO) sterilization cycle parameters, including optimization of EO concentration, for the Nerve Cuff Electrode of the Altius System

Current openFDA PMA Record#

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S004
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2025-06-05
Decision code: OK30
Date received: 2025-05-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes in the ethylene oxide (EO) sterilization cycle parameters, including optimization of EO concentration, for the Nerve Cuff Electrode of the Altius System