Ams Acticon Neosphincter

FDA premarket approval P010020 · Implanted fecal incontinence device

PMA numberP010020

Approval

Applicant
Boston Scientific Corp
Received
March 30, 2001
Decision date
December 18, 2001 (APWD)
Supplements
32, latest February 4, 2016
Product code
MIP – Implanted Fecal Incontinence Device

Official FDA PMA record

Approval order statement

APPROVAL FOR THE AMS ACTICON NEOSPHINCTER SYSTEM. THIS DEVICE IS INDICATED TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOT CANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.