PMA
P040008: VIDAS TPSA ASSAY
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · bioMerieux, Inc.
Key facts
| PMA number | P040008 |
|---|---|
| Trade name | VIDAS TPSA ASSAY |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | bioMerieux, Inc. |
| Owner/operator | BIOMERIEUX SA |
| Product code | MTF |
| Approval date | Jul 8, 2004 |
| Docket number | 04M-0342 |
| Notice date | Aug 4, 2004 |
| Establishment registration | 3002769706 |
| FEI number | 3002769706 |
At a glance
- 10–99 Supplements
- May 31, 2016 Latest supplement decision
- Yes Withdrawn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: