PMA supplement
P100024 S011: HER2 CISH PHARMDX KIT
FDA PMA supplement · Real-Time Process · Dako Denmark A/S
Key facts
| Original PMA | P100024 |
|---|---|
| Supplement number | S011 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | HER2 CISH PHARMDX KIT |
| Generic name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Applicant | Dako Denmark A/S |
| Product code | NYQ |
| Received date | Dec 27, 2016 |
| Decision date | Mar 24, 2017 |
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: