|
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 |
Supplement Number | S001 |
Date Received | 03/30/2022 |
Decision Date | 08/17/2022 |
Product Code |
QPT |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Post-Approval Study of eCoin® for treatment of urgency urinary incontinence (UUI) which is designed to collect effectiveness and safety data in a post-approval setting. |