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 |