PMA P000053S128
- Device
- AMS 800™ Artificial Urinary Sphincter (AUS) with and without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S128
- Product code
- EZY
- Decision date
- 2022-11-14
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Process change to add an automated device verification before the sterile packaging process.
Current openFDA PMA Record#
- Device
- AMS 800™ Artificial Urinary Sphincter (AUS) with and without InhibiZone™
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S128
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2022-11-14
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change to add an automated device verification before the sterile packaging process.