PMA supplement
P890025 S012: TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD
FDA PMA supplement · Real-Time Process · Abbott Laboratories
Key facts
| Original PMA | P890025 |
|---|---|
| Supplement number | S012 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD |
| Generic name | Fluorescence polarization immunoassay for cyclosporine |
| Applicant | Abbott Laboratories |
| Product code | MGU |
| Received date | Sep 23, 1999 |
| Decision date | Sep 29, 1999 |
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: