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: Assurity MRI and Endurity MRI
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P140033
• Supplement Number: S032
• Date Received: 05/21/2018
• Decision Date: 06/15/2018
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implementation of an automated environment monitoring system.