PMA P130018S005

Device: ProACT™ Adjustable Continence Therapy for Men
Applicant: Uromedica, Inc.
PMA number: P130018
Supplement: S005
Product code: EZY
Decision date: 2026-01-28
Classification: Gastroenterology, Urology
Generic name: Device, incontinence, mechanical/hydraulic
Approval order statement: for the addition of four potential adverse events and updates to the MRI Information section of the instructions for use

Current openFDA PMA Record#

Device: ProACT™ Adjustable Continence Therapy for Men
Applicant: Uromedica, Inc.
PMA number: P130018
Supplement: S005
Product code: EZY
Generic name: Device, incontinence, mechanical/hydraulic
Decision date: 2026-01-28
Decision code: APPR
Date received: 2025-12-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: for the addition of four potential adverse events and updates to the MRI Information section of the instructions for use