PMA P240031S005

Device: Neuspera Sacral Neuromodulation (SNM) System
Applicant: Neuspera Medical, Inc.
PMA number: P240031
Supplement: S005
Product code: EZW
Decision date: 2026-08-21
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: Approval for extension of the shelf life for the Trial System Kit, Trial Lead Kit, and External Procedural Kit of the Neuspera Trial System

Current openFDA PMA Record#

Device: Neuspera Sacral Neuromodulation (SNM) System
Applicant: Neuspera Medical, Inc.
PMA number: P240031
Supplement: S005
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2026-08-21
Decision code: APPR
Date received: 2026-06-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for extension of the shelf life for the Trial System Kit, Trial Lead Kit, and External Procedural Kit of the Neuspera Trial System