PMA supplement
P170019 S016: FoundationOne CDx (F1CDx)
FDA PMA supplement · Panel Track · Foundation Medicine, Inc.
Key facts
| Original PMA | P170019 |
|---|---|
| Supplement number | S016 |
| 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 | Jan 21, 2020 |
| Decision date | Jun 16, 2020 |
| Docket number | 20M-1612 |
| Notice date | Jun 24, 2020 |
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: