PMA supplement
P190033 S001: AAV5 DetectCDx®
FDA PMA supplement · 30-Day Notice · ARUP Laboratories
Key facts
| Original PMA | P190033 |
|---|---|
| Supplement number | S001 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | AAV5 DetectCDx® |
| Generic name | Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors |
| Applicant | ARUP Laboratories |
| Product code | QWQ |
| Received date | Sep 5, 2024 |
| Decision date | Oct 4, 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: