PMA P000053S096
- Device
- AMS 800 Artificial Urinary Sphincter
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S096
- Product code
- EZY
- Decision date
- 2018-12-20
- Classification
- Device, Incontinence, Mechanical/hydraulic
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Approval for minor labeling and packaging changes.
Current openFDA PMA Record#
- Device
- AMS 800 Artificial Urinary Sphincter
- Applicant
- Boston Scientific Corp
- PMA number
- P000053
- Supplement
- S096
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2018-12-20
- Decision code
- APPR
- Date received
- 2018-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor labeling and packaging changes.