PMA P010020S021
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S021
- Product code
- MIP
- Decision date
- 2011-10-26
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- CHANGE IN THE PACKAGING PROCESS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S021
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2011-10-26
- Decision code
- OK30
- Date received
- 2011-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE PACKAGING PROCESS FOR THE DEVICES.