PMA
P160045: Oncomine Dx Target Test
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Life Technologies Corporation
Key facts
| PMA number | P160045 |
|---|---|
| Trade name | Oncomine Dx Target Test |
| Generic name | Next generation sequencing oncology panel, somatic or germline variant detection system |
| Applicant | Life Technologies Corporation |
| Owner/operator | Life Technologies Corporation |
| Product code | PQP |
| Approval date | Jun 22, 2017 |
| Docket number | 17M-3928 |
| Notice date | Jun 23, 2017 |
| Establishment registration | 3003335080 |
| FEI number | 3003335080 |
At a glance
- 10–99 Supplements
- Mar 4, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: