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.
Updates related to the pre-cutting of the polyurethane extrusion and a change in the color of the etfe insulation for the percutaneous extension component
| Device | Axonics Sacral Neuromodulation (SNM) System Urinary Control |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | Axonics Modulation Technologies, Inc. |
| Date Received | 2021-02-25 |
| Decision Date | 2021-03-25 |
| PMA | P180046 |
| Supplement | S034 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 | |
| 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 |