PMA supplement
P090015 S006: BOND Oracle HER2 IHC System
FDA PMA supplement · Real-Time Process · Leica Biosystems
Key facts
| Original PMA | P090015 |
|---|---|
| Supplement number | S006 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | BOND Oracle HER2 IHC System |
| Generic name | SYSTEM, TEST, HER-2/NEU, IHC |
| Applicant | Leica Biosystems |
| Product code | MVC |
| Received date | Oct 26, 2018 |
| Decision date | Jan 23, 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: