PMA
P910065: AIA-PACK PSA
FDA PMA · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer · Tosoh Bioscience, Inc.
Key facts
| PMA number | P910065 |
|---|---|
| Trade name | AIA-PACK PSA |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Tosoh Bioscience, Inc. |
| Owner/operator | TOSOH BIOSCIENCE |
| Product code | MTF |
| Approval date | Jul 7, 1993 |
| Docket number | 93M-0251 |
| Notice date | Aug 10, 1993 |
| Establishment registration | 3005529799 |
| FEI number | 3005529799 |
At a glance
- 10–99 Supplements
- Jun 18, 2019 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- No Withdrawn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: