eCoin implanted tibial stimulator

FDA premarket approval P200036/S005 · decided 2023-03-13

Approval details

PMA number

P200036

Supplement

S005

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

eCoin implanted tibial stimulator

Generic name

Stimulator, tibial, electrical, implantable, for urinary incontinence

Applicant

Boston Scientific Corporation

Date received

2022-12-15

Decision date

2023-03-13

Days to decision

88 days

Decision code

APPR

Product code

QPT

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlborough, MA

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).

510(k) clearances by this applicant