- Device
- AMS 800 Artificial Urinary Sphincter (with InhibiZone)
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S134
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2024-05-23
- Decision code
- APPR
- Date received
- 2024-03-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the batch release and stability evaluation for AMS 700™ Inflatable Penile Prosthesis and AMS 800™ Artificial Urinary Sphincter with lnhibiZone products