PMA supplement
P040021 S058: Epic™ Plus Tissue Heart Valves, Epic™ Max Tissue Heart Valves, Epic™ Tissue Heart Valves
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P040021 |
|---|---|
| Supplement number | S058 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Epic™ Plus Tissue Heart Valves, Epic™ Max Tissue Heart Valves, Epic™ Tissue Heart Valves |
| Generic name | Heart-valve, non-allograft tissue |
| Applicant | ABBOTT MEDICAL |
| Product code | LWR |
| Received date | Jun 27, 2024 |
| Decision date | Jul 25, 2024 |
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: