PMA P200036S004

Device: eCoin Implant Tibial Stimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S004
Product code: QPT
Decision date: 2022-11-30
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) - A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

Current openFDA PMA Record#

Device: eCoin Implant Tibial Stimulator
Applicant: Boston Scientific Corporation
PMA number: P200036
Supplement: S004
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2022-11-30
Decision code: APPR
Date received: 2022-10-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) - A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)