PMA
P080008: VIDAS FREE PSA RT ASSAY
FDA PMA · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions · bioMerieux, Inc.
Key facts
| PMA number | P080008 |
|---|---|
| Trade name | VIDAS FREE PSA RT ASSAY |
| Generic name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Applicant | bioMerieux, Inc. |
| Owner/operator | BIOMERIEUX SA |
| Product code | MTG |
| Approval date | Oct 8, 2009 |
| Docket number | 09M-0536 |
| Notice date | Nov 5, 2009 |
| Establishment registration | 1950204 |
| FEI number | 1950204 |
At a glance
- 1–9 Supplements
- Jan 18, 2013 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: