PMA P000053S131
- Device
- AMS 800™ Artificial Urinary Sphincter with InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S131
- Product code
- EZY
- Decision date
- 2023-06-28
- Classification
- Gastroenterology, Urology
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Change to the colorant used in a manufacturing aid during InhibiZone impregnation.
Current openFDA PMA Record#
- Device
- AMS 800™ Artificial Urinary Sphincter with InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S131
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2023-06-28
- Decision code
- OK30
- Date received
- 2023-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the colorant used in a manufacturing aid during InhibiZone impregnation.