PMA P000053S127

Device: AMS 800™ Artificial Urinary Sphincter (AUS) with and without lnhibiZone™ Treatment
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S127
Product code: EZY
Decision date: 2022-09-01
Generic name: Device, incontinence, mechanical/hydraulic
Approval order statement: Process change to the Global Labeling System version 3.0 software and infrastructure from the current Minnetonka Labeling System.

Current openFDA PMA Record#

Device: AMS 800™ Artificial Urinary Sphincter (AUS) with and without lnhibiZone™ Treatment
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S127
Product code: EZY
Generic name: Device, incontinence, mechanical/hydraulic
Decision date: 2022-09-01
Decision code: OK30
Date received: 2022-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Process change to the Global Labeling System version 3.0 software and infrastructure from the current Minnetonka Labeling System.