PMA P200036S008
- Device
- eCoin Peripheral Neurostimulator
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S008
- Product code
- QPT
- Decision date
- 2025-07-16
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Approval order statement
- Approval for PAS protocol revisions including the addition of sites
Current openFDA PMA Record#
- Device
- eCoin Peripheral Neurostimulator
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S008
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2025-07-16
- Decision code
- APPR
- Date received
- 2025-06-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for PAS protocol revisions including the addition of sites