PMA
P170037: Sangia Total PSA Test
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Opko Diagnostics, LLC
Key facts
| PMA number | P170037 |
|---|---|
| Trade name | Sangia Total PSA Test |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Opko Diagnostics, LLC |
| Product code | MTF |
| Approval date | Jan 30, 2019 |
| Docket number | 19M-0505 |
| Notice date | Jan 31, 2019 |
| FEI number | 3010909452 |
At a glance
- None Supplements
- Jan 30, 2019 Latest supplement decision
- No Withdrawn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: