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: ANTHEM, ALLURE/RF, QUADRA ALLURE/RF FAMILY OF CRT-PS
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P030035
• Supplement Number: S139
• Date Received: 09/15/2015
• Decision Date: 05/12/2016
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.