Approval for the axonics sacral neuromodulation system. The device is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
| Device | Axonics Sacral Neuromodulation System |
| Classification Name | Stimulator, Electrical, Implantable, For Incontinence |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | Axonics Modulation Technologies, Inc. |
| Date Received | 2018-12-06 |
| Decision Date | 2019-11-13 |
| Notice Date | 2019-11-14 |
| PMA | P180046 |
| Supplement | S |
| Product Code | EZW |
| Docket Number | 19M-5393 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180046 | | Original Filing |
| S064 |
2023-01-10 |
30-day Notice |
| S063 | | |
| S062 |
2022-09-29 |
Normal 180 Day Track |
| S061 |
2022-09-19 |
Normal 180 Day Track |
| S060 |
2022-08-15 |
30-day Notice |
| S059 |
2022-08-11 |
30-day Notice |
| S058 | | |
| S057 |
2022-06-30 |
30-day Notice |
| S056 | | |
| S055 |
2022-04-15 |
30-day Notice |
| S054 | | |
| S053 | | |
| S052 |
2022-03-24 |
30-day Notice |
| S051 |
2022-02-07 |
30-day Notice |
| S050 |
2022-01-14 |
30-day Notice |
| S049 |
2022-01-05 |
30-day Notice |
| S048 | | |
| S047 |
2021-12-15 |
30-day Notice |
| S046 | | |
| S045 |
2021-12-07 |
30-day Notice |
| S044 | | |
| S043 |
2021-10-27 |
30-day Notice |
| S042 |
2021-10-18 |
30-day Notice |
| S041 | | |
| S040 | | |
| S039 | | |
| S038 | | |
| S037 |
2021-04-26 |
30-day Notice |
| S036 | | |
| S035 | | |
| S034 |
2021-02-25 |
30-day Notice |
| S033 |
2021-02-16 |
30-day Notice |
| S032 |
2021-02-08 |
30-day Notice |
| S031 |
2021-02-01 |
30-day Notice |
| S030 |
2021-02-01 |
30-day Notice |
| S029 |
2021-01-25 |
30-day Notice |
| S028 | | |
| S027 | | |
| S026 |
2020-11-05 |
Real-time Process |
| S025 | | |
| S024 | | |
| S023 |
2020-10-06 |
30-day Notice |
| S022 |
2020-10-02 |
30-day Notice |
| S021 |
2020-08-24 |
30-day Notice |
| S020 | | |
| S019 |
2020-07-02 |
30-day Notice |
| S018 |
2020-06-16 |
30-day Notice |
| S017 |
2020-06-12 |
30-day Notice |
| S016 |
2020-06-05 |
30-day Notice |
| S015 | | |
| S014 | | |
| S013 | | |
| S012 | | |
| S011 |
2020-04-02 |
Normal 180 Day Track |
| S010 |
2020-03-16 |
30-day Notice |
| S009 |
2020-03-11 |
30-day Notice |
| S008 |
2020-03-06 |
30-day Notice |
| S007 |
2020-03-06 |
30-day Notice |
| S006 | | |
| S005 |
2020-01-31 |
30-day Notice |
| S004 | | |
| S003 |
2020-01-17 |
30-day Notice |
| S002 | | |
| S001 | | |
NIH GUDID Devices