PMA P230020S003

Device: Altius Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S003
Product code: SAZ
Decision date: 2025-06-25
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 second battery charge current option of 100 mA, in addition to the battery charge current of 50 mA previously approved under the original PMA P230020.

Current openFDA PMA Record#

Device: Altius Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S003
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2025-06-25
Decision code: APPR
Date received: 2025-04-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a second battery charge current option of 100 mA, in addition to the battery charge current of 50 mA previously approved under the original PMA P230020.