PMA P010020S020
- Device
- Acticon Neosphincter
- Applicant
- Boston Scientific Corp.
- PMA number
- P010020
- Supplement
- S020
- Decision date
- 2010-12-22
Current openFDA PMA Record
- Device
- ACTICON NEOSPHINCTER
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S020
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2010-12-22
- Decision code
- OK30
- Date received
- 2010-11-26
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE CONTRACT MANUFACTURING SITE OF A COMPONENT.