PMA supplement
P850048 S009: HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC
FDA PMA supplement · Panel Track · Beckman Coulter, Inc.
Key facts
| Original PMA | P850048 |
|---|---|
| Supplement number | S009 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Beckman Coulter, Inc. |
| Product code | LTJ |
| Received date | Jun 29, 1992 |
| Decision date | Aug 25, 1994 |
| Docket number | 94M-0327 |
| Notice date | Oct 14, 1994 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: