- Device
- AMS 800 Artificial Urinary Sphincter (with and without InhibiZone)
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S130
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2024-10-08
- Decision code
- APPR
- Date received
- 2023-05-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for material and manufacturing process changes to the pressure regulation balloon (PRB) component of the AMS 800 Artificial Urinary Sphincter