PMA supplement
P920030 S002: CIBA CORNING ACS PSA IMMUNOASSAY
FDA PMA supplement · Panel Track · Bayer Healthcare, LLC
Key facts
| Original PMA | P920030 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CIBA CORNING ACS PSA IMMUNOASSAY |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Bayer Healthcare, LLC |
| Product code | LTJ |
| Received date | Apr 20, 1998 |
| Decision date | Dec 8, 1998 |
| Docket number | 00M-1536 |
| Notice date | Sep 27, 2000 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: