PMA supplement
P100027 S030: INFORM HER2 Dual ISH DNA Probe Cocktail assays
FDA PMA supplement · Normal 180 Day Track · Ventana Medical Systems, Inc.
Key facts
| Original PMA | P100027 |
|---|---|
| Supplement number | S030 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | INFORM HER2 Dual ISH DNA Probe Cocktail assays |
| Generic name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Applicant | Ventana Medical Systems, Inc. |
| Product code | NYQ |
| Received date | Feb 13, 2019 |
| Decision date | May 3, 2019 |
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: