eCoin Peripheral Neurostimulator
FDA premarket approval P200036/S008 · decided 2025-07-16
Approval details
- PMA number
- P200036
- Supplement
- S008
- 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
- 2025-06-20
- Decision date
- 2025-07-16
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for PAS protocol revisions including the addition of sites
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