PMA supplement
P160038 S019: Praxis Extended RAS Panel
FDA PMA supplement · Normal 180 Day Track No User Fee · Illumina, Inc.
Key facts
| Original PMA | P160038 |
|---|---|
| Supplement number | S019 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Praxis Extended RAS Panel |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Illumina, Inc. |
| Product code | PQP |
| Received date | Dec 30, 2020 |
| Decision date | Jul 29, 2021 |
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: