This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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 | P180046 |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180046 | Original Filing | |
| 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 |