PMA P000053S135

Device: AMS 800™ Artificial Urinary Sphincter with and without InhibiZone™
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S135
Product code: EZY
Decision date: 2024-05-29
Classification: Gastroenterology, Urology
Generic name: Device, incontinence, mechanical/hydraulic
Approval order statement: a change to the supplier-provided adhesive formulation applied to Tyvek lids at the supplier. The Tyvek lids with the adhesive are supplied to BSC and used to seal the lids to plastic trays to create the sterile barrier

Current openFDA PMA Record#

Device: AMS 800™ Artificial Urinary Sphincter with and without InhibiZone™
Applicant: Boston Scientific Corp
PMA number: P000053
Supplement: S135
Product code: EZY
Generic name: Device, incontinence, mechanical/hydraulic
Decision date: 2024-05-29
Decision code: OK30
Date received: 2024-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the supplier-provided adhesive formulation applied to Tyvek lids at the supplier. The Tyvek lids with the adhesive are supplied to BSC and used to seal the lids to plastic trays to create the sterile barrier