PMA supplement
P030054 S436: Quartet™ 1456Q, 1457Q, 1458Q, 1458QL; Avant™ HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant™ HF CDHFA500B, CDHFA
FDA PMA supplement · Real-Time Process · ABBOTT MEDICAL
Key facts
| Original PMA | P030054 |
|---|---|
| Supplement number | S436 |
| Supplement type | Real-Time Process |
| Reason for the supplement | 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 |
| Product code | NIK |
| Received date | May 29, 2025 |
| Decision date | Aug 27, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: