| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Neuspera Sacral Neuromodulation System |
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| Generic Name | Stimulator, electrical, implantable, for incontinence |
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| Regulation Number | 876.5270 |
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| Applicant | Neuspera Medical, Inc.
51 Daggett Dr.
San Jose, CA 95134 |
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| PMA Number | P240031 |
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| Date Received | 09/23/2024 |
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| Decision Date | 06/17/2025 |
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| Product Code |
EZW |
| Docket Number | 25M-1810 |
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| Notice Date | 06/20/2025 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Clinical Trials | NCT04232696
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval of the Neuspera Sacral Neuromodulation System. The device is indicated for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S003 S004 |
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