PMA
P090015: BOND ORACLE HER2 IHC SYSTEM
FDA PMA · SYSTEM, TEST, HER-2/NEU, IHC · Leica Biosystems
Key facts
| PMA number | P090015 |
|---|---|
| Trade name | BOND ORACLE HER2 IHC SYSTEM |
| Generic name | SYSTEM, TEST, HER-2/NEU, IHC |
| Applicant | Leica Biosystems |
| Owner/operator | Leica Biosystems, division of Leica Microsystems, Inc. |
| Product code | MVC |
| Approval date | Apr 18, 2012 |
| Docket number | 12M-0390 |
| Notice date | Apr 25, 2012 |
| Establishment registration | 3006791373 |
| FEI number | 3006791373 |
At a glance
- 10–99 Supplements
- Jun 4, 2026 Latest supplement decision
- No Withdrawn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: