- Device
- AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S118
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a process change to upgrade the molding process of the silicone valve block and curved cuff components and move to a controlled, non-classified molding room