| Device | eCoin Peripheral Neurostimulator |
| Generic Name | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
| Applicant | Valencia Technologies Corporation28464 Westinghouse Placevalencia, CA 91355 PMA NumberP200036 Date Received08/10/2020 Decision Date03/01/2022 Product Code QPT Advisory Committee Gastroenterology/Urology Clinical TrialsNCT03556891 Expedited Review Granted? No |
| Date Received | 2020-08-10 |
| Decision Date | 2022-03-01 |
| PMA | P200036 |
| Supplement | S |
| Product Code | QPT |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Valencia Technologies Corporation 28464 Westinghouse Place valencia, CA 91355 PMA NumberP200036 Date Received08/10/2020 Decision Date03/01/2022 Product Code QPT Advisory Committee Gastroenterology/Urology Clinical TrialsNCT03556891 Expedited Review Granted? No Combination ProductNo Approval Order Statement The ECoin® Peripheral Neurostimulator 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. Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200036 | Original Filing | |
| S004 | 2022-10-31 | Normal 180 Day Track No User Fee |
| S003 | 2022-04-26 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00860007896965 | P200036 | 000 |
| 00860007896910 | P200036 | 000 |
| 00860007896903 | P200036 | 000 |
| 00860007896972 | P200036 | 005 |