PMA P130018S004

Device: ProACT™ Adjustable Continence Therapy for Men
Applicant: Uromedica, Inc.
PMA number: P130018
Supplement: S004
Product code: EZY
Decision date: 2025-10-03
Classification: Gastroenterology, Urology
Generic name: Device, incontinence, mechanical/hydraulic
Approval order statement: Approval of the modifications to the study protocol including expansion of the study to 10-14 study sites and modifications to the Informed Consent Form for the post-approval study.

Current openFDA PMA Record#

Device: ProACT™ Adjustable Continence Therapy for Men
Applicant: Uromedica, Inc.
PMA number: P130018
Supplement: S004
Product code: EZY
Generic name: Device, incontinence, mechanical/hydraulic
Decision date: 2025-10-03
Decision code: APPR
Date received: 2025-09-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the modifications to the study protocol including expansion of the study to 10-14 study sites and modifications to the Informed Consent Form for the post-approval study.