- Device
- AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S136
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2025-01-23
- Decision code
- OK30
- Date received
- 2025-01-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the removal of in-process cytotoxicity testing at the component level for the AMS 800™ Artificial Urinary Sphincter with/without InhibiZone™