PMA P000053S121
- Device
- AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S121
- Product code
- EZY
- Decision date
- 2021-07-08
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Addition of two sterilization chambers to conduct ethylene oxide gas sterilization Cycle 101.
Current openFDA PMA Record#
- Device
- AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S121
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2021-07-08
- Decision code
- OK30
- Date received
- 2021-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two sterilization chambers to conduct ethylene oxide gas sterilization Cycle 101.