PMA P010020

Device: AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS)
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S029
Product code: MIP
Decision date: 2016-02-04
Generic name: Implanted fecal incontinence device
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.

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.