PMA P000053S137

Device: AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S137
Product code: EZY
Decision date: 2025-06-03
Classification: Gastroenterology, Urology
Generic name: Device, incontinence, mechanical/hydraulic
Approval order statement: approval for changes to the AMS 800 product packaging artwork, product labels, eLabeling Access Statement Insert, Physician Instructions for Use, Magnetic Resonance Imaging (MRI) Safety Information to support the MR Conditional labeling, and Patient Guide

Current openFDA PMA Record#

Device: AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S137
Product code: EZY
Generic name: Device, incontinence, mechanical/hydraulic
Decision date: 2025-06-03
Decision code: APPR
Date received: 2025-03-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for changes to the AMS 800 product packaging artwork, product labels, eLabeling Access Statement Insert, Physician Instructions for Use, Magnetic Resonance Imaging (MRI) Safety Information to support the MR Conditional labeling, and Patient Guide