PMA P200036S006
- Device
- eCoin implanted tibial stimulator
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S006
- Product code
- QPT
- Decision date
- 2023-06-12
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Approval order statement
- Approval for an additional battery supplier for the eCoin implanted tibial stimulator
Current openFDA PMA Record#
- Device
- eCoin implanted tibial stimulator
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S006
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2023-06-12
- Decision code
- APPR
- Date received
- 2023-03-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an additional battery supplier for the eCoin implanted tibial stimulator