Approval for the axonics sacral neuromodulation system. This device is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for 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 | 2019-03-04 |
| Decision Date | 2019-09-06 |
| PMA | P190006 |
| Supplement | S |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190006 | | 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 |
2019-12-30 |
30-day Notice |
| S002 |
2019-10-18 |
Real-time Process |
| S001 | | |
NIH GUDID Devices