|
Device | AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS) |
Generic Name | Implanted fecal incontinence device |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P010020 |
Supplement Number | S029 |
Date Received | 02/27/2015 |
Decision Date | 02/04/2016 |
Withdrawal Date
|
12/12/2016 |
Product Code |
MIP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
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. |