PMA supplement
BP170154 S011: ID CORE XT
FDA PMA supplement · 30-Day Notice · Progenika Biopharma, S.A.
Key facts
| Original PMA | BP170154 |
|---|---|
| Supplement number | S011 |
| Supplement type | 30-Day Notice |
| Trade name | ID CORE XT |
| Generic name | Molecular erythrocyte typing test |
| Applicant | Progenika Biopharma, S.A. |
| Product code | PEP |
| Received date | Mar 21, 2022 |
| Decision date | Apr 12, 2022 |
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: