PMA P230020S006

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S006
Product code: SAZ
Decision date: 2026-05-05
Classification: Neurology
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Approval order statement: approval for the addition of an alternate test method (Bacterial Endotoxin Testing Chromogenic) for endotoxin testing of the Implantable Pulse Generator (IPG) and IPG Accessory Kit components of the Altius System and a change in the test lab supplier for endotoxin testing from Integer Uruguay to Labcorp and Integer Plymouth.

Current openFDA PMA Record#

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S006
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2026-05-05
Decision code: APPR
Date received: 2025-11-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the addition of an alternate test method (Bacterial Endotoxin Testing Chromogenic) for endotoxin testing of the Implantable Pulse Generator (IPG) and IPG Accessory Kit components of the Altius System and a change in the test lab supplier for endotoxin testing from Integer Uruguay to Labcorp and Integer Plymouth.