Approval for an update to the software and associated labeling for the model 1101 implantable neurostimulator and model 2501 clinician programmer to support the use of two therapy programs.
| Device | Axonics Sacral Neuromodulation System |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | Axonics Modulation Technologies, Inc. |
| Date Received | 2020-11-05 |
| Decision Date | 2021-02-03 |
| PMA | P190006 |
| Supplement | S026 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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