PMA P010020S026

Device: AMS ACTICON NEOPHINCTER
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S026
Product code: MIP
Decision date: 2012-10-05
Generic name: Implanted fecal incontinence device
Approval order statement: THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES.

Current openFDA PMA Record

Device: AMS ACTICON NEOPHINCTER
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S026
Product code: MIP
Generic name: Implanted fecal incontinence device
Decision date: 2012-10-05
Decision code: OK30
Date received: 2012-09-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES.