eCoin Implant Tibial Stimulator
FDA premarket approval P200036/S004 · decided 2022-11-30
Approval details
- PMA number
- P200036
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- eCoin Implant Tibial Stimulator
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-10-31
- Decision date
- 2022-11-30
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- 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)
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| 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 |