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 |