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.
| Device | Axonics Sacral Neuromodulation System (Urinary) |
| Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
| Applicant | Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-19 |
| Decision Date | 2022-11-01 |
| PMA | P180046 |
| Supplement | S061 |
| Product Code | EZW |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For A Manufacturing Site Located At Cirtec Medical Corporation, 99 Print Shop Road Enfield, CT 06082 As An Alternate Contract Ethylene Oxide Sterilization Facility For The Axonics Neurostimulator, Model 4101. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 10810005340486 | P180046 | 000 |
| 10810005340431 | P180046 | 015 |
| 10810005340424 | P180046 | 015 |
| 10810005340455 | P180046 | 038 |
| 10810005340479 | P180046 | 056 |
| 10810005340578 | P180046 | 086 |