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 Implant Tibial Stimulator |
| Generic Name | Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence |
| Applicant | Valencia Technologies Corporation28464 Westinghouse Placevalencia, CA 91355 PMA NumberP200036 Supplement NumberS004 Date Received10/31/2022 Decision Date11/30/2022 Product Code QPT Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-10-31 |
| Decision Date | 2022-11-30 |
| PMA | P200036 |
| Supplement | S004 |
| 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 NumberS004 Date Received10/31/2022 Decision Date11/30/2022 Product Code QPT Advisory Committee Gastroenterology/Urology 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 Revised Protocol For The Post-approval Study (PAS) - A Real World Study Of ECoin For Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE) |
| 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 |