PMA P200036S005

Device: eCoin implanted tibial stimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S005
Product code: QPT
Decision date: 2023-03-13
Classification: Gastroenterology, Urology
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: Approval for a modification to the printed circuit board assembly component of the External Controller, a reduction in the number of External Controller and its associated accessories (adaptors, radios, and antennas) included in the kit to one, and changes to the External Controller labeling (i.e., minor clarifications and to reflect the change in kit components).

Current openFDA PMA Record#

Device: eCoin implanted tibial stimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S005
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2023-03-13
Decision code: APPR
Date received: 2022-12-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the printed circuit board assembly component of the External Controller, a reduction in the number of External Controller and its associated accessories (adaptors, radios, and antennas) included in the kit to one, and changes to the External Controller labeling (i.e., minor clarifications and to reflect the change in kit components).