PMA
P990056: ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Roche Diagnostics Corp.
Key facts
| PMA number | P990056 |
|---|---|
| Trade name | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Roche Diagnostics Corp. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MTF |
| Approval date | Nov 22, 2000 |
| Docket number | 00M-1660 |
| Notice date | Dec 12, 2000 |
| Establishment registration | 9610529 |
| FEI number | 3002806560 |
At a glance
- 10–99 Supplements
- Apr 29, 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- No Withdrawn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: