PMA supplement
P800061 S001: RIANEN I125
FDA PMA supplement · Dupont Legal
Key facts
| Original PMA | P800061 |
|---|---|
| Supplement number | S001 |
| Trade name | RIANEN I125 |
| Generic name | KIT, ASSAY, ESTROGEN RECEPTOR |
| Applicant | Dupont Legal |
| Product code | LPJ |
| Received date | Oct 22, 1980 |
| Decision date | Jun 2, 1981 |
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: