PMA P010020S025
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S025
- Product code
- MIP
- Decision date
- 2012-08-02
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S025
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2012-08-02
- Decision code
- OK30
- Date received
- 2012-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE LABEL DATABASE SERVER AND A LABELING SOFTWARE REVISION TO THE NICELABEL SYSTEM.