eCoin Peripheral Neurostimulator
FDA premarket approval P200036/S001 · decided 2022-08-17
Approval details
- PMA number
- P200036
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- eCoin Peripheral Neurostimulator
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-03-30
- Decision date
- 2022-08-17
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the Post-Approval Study of eCoin® for treatment of urgency urinary incontinence (UUI) which is designed to collect effectiveness and safety data in a post-approval setting.
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