|
Device | eCoin Peripheral Neurostimulator |
Generic Name | Stimulator, tibial, electrical, implantable, for urinary incontinence |
Applicant | Valencia Technologies Corporation 28464 Westinghouse Place Valencia, CA 91355 |
PMA Number | P200036 |
Date Received | 08/10/2020 |
Decision Date | 03/01/2022 |
Product Code |
QPT |
Docket Number | 22M-0298 |
Notice Date | 03/08/2022 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT03556891
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the eCoin® Peripheral Neurostimulator. The device is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S003 S004 S005 S006 |