PMA P230020S001

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S001
Product code: SAZ
Decision date: 2024-12-19
Classification: Neurology
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Approval order statement: the replacement of a sub-component of EPO-TEK® 301 epoxy, known as Part A, with an equivalent material sourced from a different supplier

Current openFDA PMA Record#

Device: Altius® Direct Electrical Nerve Stimulation System
Applicant: Neuros Medical, Inc.
PMA number: P230020
Supplement: S001
Product code: SAZ
Generic name: stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Decision date: 2024-12-19
Decision code: OK30
Date received: 2024-11-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the replacement of a sub-component of EPO-TEK® 301 epoxy, known as Part A, with an equivalent material sourced from a different supplier