PMA P010020S029
- Device
- Ams Acticon Neosphincter Artificial Bowel Sphincte
- Applicant
- Boston Scientific Corp.
- PMA number
- P010020
- Supplement
- S029
- Decision date
- 2016-02-04
Current openFDA PMA Record
- Device
- AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010020
- Supplement
- S029
- Product code
- MIP
- Generic name
- Implanted fecal incontinence device
- Decision date
- 2016-02-04
- Decision code
- APPR
- Date received
- 2015-02-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- Approval for the implementation of a replacement injection mold, a contract molding service supplier change and a change to the outgassing process related to the collet component of the three devices.