PMA supplement
P170019 S043: FoundationOne CDx (F1CDx)
FDA PMA supplement · Panel Track · Foundation Medicine, Inc.
Key facts
| Original PMA | P170019 |
|---|---|
| Supplement number | S043 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FoundationOne CDx (F1CDx) |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Foundation Medicine, Inc. |
| Product code | PQP |
| Received date | Mar 2, 2023 |
| Decision date | Oct 6, 2023 |
| Docket number | 23M-4878 |
| Notice date | Nov 9, 2023 |
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: