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Quartet™ 1456Q, 1457Q, 1458Q, 1458QL; Avant™ HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant™ HF CDHFA500B, CDHFA

FDA premarket approval P030054/S436 · decided 2025-08-27

Approval details

PMA number
P030054
Supplement
S436
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Quartet™ 1456Q, 1457Q, 1458Q, 1458QL; Avant™ HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant™ HF CDHFA500B, CDHFA
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
ABBOTT MEDICAL
Date received
2025-05-29
Decision date
2025-08-27
Days to decision
90 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
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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