PMA
P100024: HER2 CISH PHARMDX KIT
FDA PMA · Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer · Dako Denmark A/S
Key facts
| PMA number | P100024 |
|---|---|
| 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 |
| Approval date | Nov 30, 2011 |
| Docket number | 11M-0866 |
| Notice date | Dec 9, 2011 |
At a glance
- 10–99 Supplements
- Apr 12, 2017 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: