PMA P010020S033

Device: ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S033
Product code: MIP
Decision date: 2015-06-24
Generic name: Implanted fecal incontinence device
Approval order statement: QUALIFICATION OF THE LASER FIXTURE METHOD AS A REPLACEMENT FOR THE CURRENT CALIPER METHOD USED FOR MEASURING A CRITICAL TUBE DIMENSION.

Current openFDA PMA Record#

Device: ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Applicant: Boston Scientific Corp
PMA number: P010020
Supplement: S033
Product code: MIP
Generic name: Implanted fecal incontinence device
Decision date: 2015-06-24
Decision code: OK30
Date received: 2015-06-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: QUALIFICATION OF THE LASER FIXTURE METHOD AS A REPLACEMENT FOR THE CURRENT CALIPER METHOD USED FOR MEASURING A CRITICAL TUBE DIMENSION.