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: Allure, Allure Quadra, Quadra Allure MP, and Anthem
• Generic Name: pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
• Applicant: Abbott Medical; 15900 valley view court; sylmar, CA 91335
• PMA Number: P030035
• Supplement Number: S170
• Date Received: 05/21/2018
• Decision Date: 06/15/2018
• Product Code: NKE
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Implementation of an automated environment monitoring system.