PMA P200036
- Device
- eCoin Peripheral Neurostimulator
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S004
- Product code
- QPT
- Decision date
- 2026-09-09
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Approval order statement
- a change in the frequency of setting the bioburden recovery efficiency
Current openFDA PMA Record#
- Device
- eCoin Peripheral Neurostimulator
- Applicant
- Boston Scientific Corporation
- PMA number
- P200036
- Supplement
- S012
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2026-09-09
- Decision code
- OK30
- Date received
- 2026-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the frequency of setting the bioburden recovery efficiency