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 |
| Generic Name | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence |
| Applicant | Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS052 Date Received03/24/2022 Decision Date04/20/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-24 |
| Decision Date | 2022-04-20 |
| PMA | P190006 |
| Supplement | S052 |
| Product Code | QON |
| 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 PMA NumberP190006 Supplement NumberS052 Date Received03/24/2022 Decision Date04/20/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement remove High Potential Testing (hipot) From Receiving Inspection For The Tined Lead When Redundant With Hipot Testing Done By The Tined Lead Contract Manufacturer |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 10810005340387 | P190006 | 000 |
| 10810005340158 | P190006 | 000 |
| 10810005340141 | P190006 | 000 |
| 10810005340134 | P190006 | 000 |
| 10810005340127 | P190006 | 000 |
| 10810005340103 | P190006 | 000 |
| 10810005340080 | P190006 | 000 |
| 10810005340066 | P190006 | 000 |
| 10810005340059 | P190006 | 000 |
| 10810005340035 | P190006 | 000 |
| 10810005340028 | P190006 | 000 |
| 10810005340189 | P190006 | 000 |
| 10810005340196 | P190006 | 000 |
| 10810005340219 | P190006 | 000 |
| 10810005340370 | P190006 | 000 |
| 10810005340325 | P190006 | 000 |
| 10810005340301 | P190006 | 000 |
| 10810005340288 | P190006 | 000 |
| 10810005340271 | P190006 | 000 |
| 10810005340264 | P190006 | 000 |
| 10810005340257 | P190006 | 000 |
| 10810005340240 | P190006 | 000 |
| 10810005340233 | P190006 | 000 |
| 10810005340226 | P190006 | 000 |
| 10810005340011 | P190006 | 000 |