PMA supplement
P840035 S003: TANDEM(R)-E AFP
FDA PMA supplement · Panel Track · Beckman Coulter, Inc.
Key facts
| Original PMA | P840035 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TANDEM(R)-E AFP |
| Generic name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Applicant | Beckman Coulter, Inc. |
| Product code | LOJ |
| Received date | Apr 3, 1986 |
| Decision date | Apr 29, 1988 |
| Docket number | 88M-0184 |
| Notice date | Jun 27, 1988 |
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: