PMA P010020S013

Device: ACTICON ARTIFICAL BOWEL SPHINCTER (ABS)
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S013
Product code: MIP
Decision date: 2009-04-08
Classification: Gastroenterology, Urology
Generic name: Implanted fecal incontinence device
Approval order statement: USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER.

Current openFDA PMA Record#

Device: ACTICON ARTIFICAL BOWEL SPHINCTER (ABS)
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S013
Product code: MIP
Generic name: Implanted fecal incontinence device
Decision date: 2009-04-08
Decision code: OK30
Date received: 2009-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF AN ALTERNATE FLOW METER TO BE USED DURING THE TESTING OF THE DEVICES¿ CONTROL PUMP AND THE USE OF AN ALTERNATE DISINFECTANT CLEANER FOR SANITIZATION OF THE DEVICE TESTER.