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 | P190006 |
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 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P190006 | | 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 |
2019-12-30 |
30-day Notice |
S002 |
2019-10-18 |
Real-time Process |
S001 | | |
NIH GUDID Devices