|
Device | Axonics Sacral Neuromodulation System |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | Boston Scientific Corporation 100 BOSTON SCIENTFIC WAY MARLBOROUGH, MA 01752 |
PMA Number | P180046 |
Date Received | 12/06/2018 |
Decision Date | 11/13/2019 |
Product Code |
EZW |
Docket Number | 19M-5393 |
Notice Date | 11/14/2019 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT03327948
|
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Approval Order Statement Approval for the Axonics Sacral Neuromodulation System. The device is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S042 S043 S044 S051 S011 S013 S061 S062 S063 S036 S037 S027 S021 S015 S016 S017 S018 S019 S020 S005 S066 S067 S068 S071 S072 S073 S084 S090 S091 S092 S077 S078 S079 S080 S022 S001 S002 S003 S004 S006 S007 S008 S009 S010 S056 S057 S032 S033 S034 S023 S024 S025 S026 S059 S060 S038 S052 S054 S055 S045 S046 S047 S049 S050 S041 S029 S030 S031 S064 S065 S097 S074 S087 S088 S089 S081 S082 S083 S093 S094 S095 S096 S098 S075 S076 S085 S086 S069 |