PMA P000053S126
- Device
- AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S126
- Product code
- EZY
- Decision date
- 2022-07-06
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Use of a new, automated control pump functional tester.
Current openFDA PMA Record#
- Device
- AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S126
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2022-07-06
- Decision code
- OK30
- Date received
- 2022-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new, automated control pump functional tester.