PMA P010020S024
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S024
- Product code
- MIP
- Decision date
- 2012-09-04
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS ACTICON CONTROL PUMP, A COMPONENT OF THE AMS ACTICON NEOSPHINCTER.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S024
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2012-09-04
- Decision code
- APPR
- Date received
- 2012-06-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS ACTICON CONTROL PUMP, A COMPONENT OF THE AMS ACTICON NEOSPHINCTER.