PMA supplement
P950021 S001: BAYER IMMUNO 1 SYSTEM
FDA PMA supplement · Panel Track · Siemens Healthcare Diagnostics
Key facts
| Original PMA | P950021 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | BAYER IMMUNO 1 SYSTEM |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Siemens Healthcare Diagnostics |
| Product code | LTJ |
| Received date | Dec 22, 1998 |
| Decision date | Jun 25, 1999 |
| Docket number | 99M-2748 |
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: