- Device
- AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S124
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2022-04-01
- Decision code
- OK30
- Date received
- 2022-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change to the water bath monitoring requirements for assembly of the AMS 700 and AMS 800.