eCoin (Electroceutical Coin)
FDA premarket approval P200036/S003 · decided 2022-07-15
Approval details
- PMA number
- P200036
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- eCoin (Electroceutical Coin)
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-04-26
- Decision date
- 2022-07-15
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- 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.
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510(k) clearances by this applicant
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|---|---|---|
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
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| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
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| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| MOSES Raydar™ (K260100) | Boston Scientific Corporation | 2026-05-18 |
| TruSelect™ 2.6 Microcatheter (K260771) | Boston Scientific Corporation | 2026-05-15 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |