PMA P230020S007

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S007
Product code: SAZ
Decision date: 2026-02-28
Classification: Neurology
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Approval order statement: approval for a change in a lubricant component used in the manufacturing of the Altius Nerve Cuff Electrode from an animal-derived to a non-animal derived source.

Current openFDA PMA Record#

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S007
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2026-02-28
Decision code: OK30
Date received: 2026-01-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a change in a lubricant component used in the manufacturing of the Altius Nerve Cuff Electrode from an animal-derived to a non-animal derived source.