PMA supplement
P230016 S001: MAGE-A4 IHC 1F9 pharmDx
FDA PMA supplement · Special (Immediate Track) · Agilent Technologies, Inc.
Key facts
| Original PMA | P230016 |
|---|---|
| Supplement number | S001 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MAGE-A4 IHC 1F9 pharmDx |
| Generic name | Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 |
| Applicant | Agilent Technologies, Inc. |
| Product code | SBL |
| Received date | Jan 31, 2025 |
| Decision date | Feb 28, 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: