PMA P200036S009
- Device
- eCoin Tibial Nerve Stimulator System
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S009
- Product code
- QPT
- Decision date
- 2025-10-02
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Approval order statement
- a change in supplier for the Printed Circuit Board Assembly (PCBA)
Current openFDA PMA Record#
- Device
- eCoin Tibial Nerve Stimulator System
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S009
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2025-10-02
- Decision code
- OK30
- Date received
- 2025-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in supplier for the Printed Circuit Board Assembly (PCBA)