PMA P000053S140

Device: AMS 800 Artificial Urinary Sphincter (AUS)
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S140
Product code: EZY
Decision date: 2025-07-14
Classification: Gastroenterology, Urology
Generic name: Device, incontinence, mechanical/hydraulic
Approval order statement: changes to update manufacturing instructions to ensure proper component seating prior to tray sealing and updates to the visual packaging inspection process

Current openFDA PMA Record#

Device: AMS 800 Artificial Urinary Sphincter (AUS)
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S140
Product code: EZY
Generic name: Device, incontinence, mechanical/hydraulic
Decision date: 2025-07-14
Decision code: OK30
Date received: 2025-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to update manufacturing instructions to ensure proper component seating prior to tray sealing and updates to the visual packaging inspection process