PMA P230020S002

Device: Altius Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S002
Product code: SAZ
Decision date: 2025-05-06
Classification: Neurology
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Approval order statement: Approval for an Altius Implantable Pulse Generator (IPG) Accessory Kit that includes a spare sterile port plug and torque wrench.

Current openFDA PMA Record#

Device: Altius Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S002
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2025-05-06
Decision code: APPR
Date received: 2025-02-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for an Altius Implantable Pulse Generator (IPG) Accessory Kit that includes a spare sterile port plug and torque wrench.