PMA supplement
P090015 S010: BOND ORACLE HER2 IHC SYSTEM
FDA PMA supplement · 30-Day Notice · Leica Biosystems
Key facts
| Original PMA | P090015 |
|---|---|
| Supplement number | S010 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BOND ORACLE HER2 IHC SYSTEM |
| Generic name | SYSTEM, TEST, HER-2/NEU, IHC |
| Applicant | Leica Biosystems |
| Product code | MVC |
| Received date | Dec 13, 2019 |
| Decision date | Jan 2, 2020 |
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: