Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: AMS 800 Urinary Control System with and without InhibiZone
• Generic Name: Device, incontinence, mechanical/hydraulic
• Regulation Number: 876.5280
• Applicant: Boston Scientific Corp; 100 Boston Scientific Way; Marlboro, MA 01752
• PMA Number: P000053
• Supplement Number: S082
• Date Received: 08/18/2017
• Decision Date: 09/14/2017
• Product Code: EZY
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implementation of Manufacturing Execution System software to electronically capture the device history record.