PMA P240031S004
- Device
- Neuspera Sacral Neuromodulation (SNM) System
- Applicant
- Neuspera Medical, Inc.
- PMA number
- P240031
- Supplement
- S004
- Product code
- EZW
- Decision date
- 2026-04-03
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- approval of an alternative supplier for the foreman needle component.
Current openFDA PMA Record#
- Device
- Neuspera Sacral Neuromodulation (SNM) System
- Applicant
- Neuspera Medical, Inc.
- PMA number
- P240031
- Supplement
- S004
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-04-03
- Decision code
- OK30
- Date received
- 2026-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of an alternative supplier for the foreman needle component.