PMA supplement
P170019 S033: FoundationOne CDx (FICDx)
FDA PMA supplement · Real-Time Process · Foundation Medicine, Inc.
Key facts
| Original PMA | P170019 |
|---|---|
| Supplement number | S033 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FoundationOne CDx (FICDx) |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Foundation Medicine, Inc. |
| Product code | PQP |
| Received date | Dec 23, 2021 |
| Decision date | Mar 16, 2022 |
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: