PMA P010020S022
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S022
- Product code
- MIP
- Decision date
- 2012-04-26
- Generic name
- Implanted fecal incontinence device
- Approval order statement
- IMPLEMENTATION OF ADDITIONAL MOLD PRESS EQUIPMENT AND CHANGE IN QUALIFIED SUPPLIER FOR A SPRING COMPONENT.
Current openFDA PMA Record
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S022
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2012-04-26
- Decision code
- OK30
- Date received
- 2012-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF ADDITIONAL MOLD PRESS EQUIPMENT AND CHANGE IN QUALIFIED SUPPLIER FOR A SPRING COMPONENT.