PMA supplement
P160045 S029: Oncomine Dx Target Test (ODxT Test)
FDA PMA supplement · Panel Track · Life Technologies Corporation
Key facts
| Original PMA | P160045 |
|---|---|
| Supplement number | S029 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Oncomine Dx Target Test (ODxT Test) |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Life Technologies Corporation |
| Product code | PQP |
| Received date | May 3, 2021 |
| Decision date | Sep 15, 2021 |
| Docket number | 21M-1023 |
| Notice date | Nov 8, 2021 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: