PMA
P100033: PROGENSA PCA3 ASSAY
FDA PMA · Prostrate cancer genes nucleic acid amplification test system · Gen-Probe Incorporated
Key facts
| PMA number | P100033 |
|---|---|
| Trade name | PROGENSA PCA3 ASSAY |
| Generic name | Prostrate cancer genes nucleic acid amplification test system |
| Applicant | Gen-Probe Incorporated |
| Owner/operator | HOLOGIC, INC. |
| Product code | OYM |
| Approval date | Feb 13, 2012 |
| Docket number | 12M-0173 |
| Notice date | Mar 6, 2012 |
| Establishment registration | 2024800 |
| FEI number | 2024800 |
At a glance
- 10–99 Supplements
- Jul 21, 2020 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- No Withdrawn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: