PMA P230020S005

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S005
Product code: SAZ
Decision date: 2025-12-03
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 manufacturing site located at Neuros Medical, Inc., 1212 Red Fox Road, Arden Hills, Minnesota, 55112. The main manufacturing operations performed at this facility include, but are not limited to, the receipt of sterile and non-sterile finished packaged devices ready for distribution from two contract manufacturing organization facilities, evaluation of returned devices, calibration and maintenance of inspection equipment, and serve as the specification developer and design control center.

Current openFDA PMA Record#

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S005
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2025-12-03
Decision code: APPR
Date received: 2025-07-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Neuros Medical, Inc., 1212 Red Fox Road, Arden Hills, Minnesota, 55112. The main manufacturing operations performed at this facility include, but are not limited to, the receipt of sterile and non-sterile finished packaged devices ready for distribution from two contract manufacturing organization facilities, evaluation of returned devices, calibration and maintenance of inspection equipment, and serve as the specification developer and design control center.