PMA supplement
P930027 S004: IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000
FDA PMA supplement · Panel Track · Siemens Healthcare Diagnostics, Inc.
Key facts
| Original PMA | P930027 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000 |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | LTJ |
| Received date | Jan 2, 2001 |
| Decision date | Jun 19, 2001 |
| Docket number | 01M-0535 |
| Notice date | Dec 5, 2001 |
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: