PMA
P920030: CIBA CORNING ACS PSA IMMUNOASSAY
FDA PMA · PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS · Bayer Healthcare, LLC
Key facts
| PMA number | P920030 |
|---|---|
| Trade name | CIBA CORNING ACS PSA IMMUNOASSAY |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Bayer Healthcare, LLC |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LTJ |
| Approval date | Dec 8, 1998 |
| Docket number | 94M-0349 |
| Notice date | Oct 27, 1994 |
| Establishment registration | 2432235 |
| FEI number | 2432235 |
At a glance
- 1–9 Supplements
- Dec 8, 1998 Latest supplement decision
- Yes Withdrawn
- No 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: