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: Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF,
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: Abbott Medical; 15900 Valley View Court; Sylmar, CA 91335
• PMA Number: P030054
• Supplement Number: S395
• Date Received: 08/04/2021
• Decision Date: 09/01/2021
• Product Code: NIK
• 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  
Acceptance to add an alternate supplier of connector assemblies that will be mounted on the hybrids for ICD and CRT-D devices.