PMA supplement
P100027 S014: INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
FDA PMA supplement · 30-Day Notice · Ventana Medical Systems, Inc.
Key facts
| Original PMA | P100027 |
|---|---|
| Supplement number | S014 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL |
| Generic name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Applicant | Ventana Medical Systems, Inc. |
| Product code | NYQ |
| Received date | Dec 27, 2013 |
| Decision date | Jan 22, 2014 |
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: