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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAvant™ DR CDDRA700Q, CDDRA700T; Gallant™ DR CDDRA500Q, CDDRA500T; Entrant™ DR CDDRA300Q, CDDRA300T; Neutrino™ NxT DR CDD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS479
Date Received05/29/2025
Decision Date08/27/2025
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
expansion of MR Conditial labeling for IsoFlex model 1944 pacing leads and additional Quartet LV pacing leads (75cm and 92cm) when combined with Avant, Gallant, Entrant, and Neutrino NxT implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds).
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