PMA P010020S031
- Device
- AMS ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S031
- Product code
- MIP
- Decision date
- 2015-04-15
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.
Current openFDA PMA Record
- Device
- AMS ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S031
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2015-04-15
- Decision code
- OK30
- Date received
- 2015-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.