This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | eCoin (Electroceutical Coin) |
| Generic Name | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
| Applicant | Valencia Technologies Corporation28464 Westinghouse Placevalencia, CA 91355 PMA NumberP200036 Supplement NumberS003 Date Received04/26/2022 Decision Date07/15/2022 Product Code QPT Advisory Committee Gastroenterology/Urology Clinical TrialsNCT03556891 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-04-26 |
| Decision Date | 2022-07-15 |
| PMA | P200036 |
| Supplement | S003 |
| Product Code | QPT |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Valencia Technologies Corporation 28464 Westinghouse Place valencia, CA 91355 PMA NumberP200036 Supplement NumberS003 Date Received04/26/2022 Decision Date07/15/2022 Product Code QPT Advisory Committee Gastroenterology/Urology Clinical TrialsNCT03556891 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo 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. |
| 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 |