PMA
P910007: AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Abbott Laboratories
Key facts
| PMA number | P910007 |
|---|---|
| Trade name | AXSYM TOTAL PSA & ARCHITECT TOTAL PSA |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MTF |
| Approval date | Sep 25, 1991 |
| Docket number | 91M-0411 |
| Notice date | Nov 12, 1991 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Feb 23, 2026 Latest supplement decision
- No Withdrawn
- No 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: