|
Device | Axonics Sacral Neuromodulation System |
Generic Name | stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant |
Axonics Modulation Technologies, Inc. |
26 technology drive |
irvine, CA 92618 |
|
PMA Number | P190006 |
Date Received | 03/04/2019 |
Decision Date | 09/06/2019 |
Product Code |
EZW
|
Docket Number | 19M-4186 |
Notice Date | 09/30/2019 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials |
NCT03327948
|
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval for the Axonics Sacral Neuromodulation System. This device is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
|
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 |