PMA supplement
P160040 S007: LeukoStrat CDx FLT3 Mutation Assay
FDA PMA supplement · Normal 180 Day Track · Invivoscribe Technologies, Inc.
Key facts
| Original PMA | P160040 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LeukoStrat CDx FLT3 Mutation Assay |
| Generic name | Somatic gene mutation detection system |
| Applicant | Invivoscribe Technologies, Inc. |
| Product code | OWD |
| Received date | Dec 2, 2020 |
| Decision date | Aug 26, 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: