PMA supplement
BP140143 S497: INTERCEPT(R) Blood Systerm for Platelets
FDA PMA supplement · 135 Day Track for 30 Day Notification · Cerus Corporation
Key facts
| Original PMA | BP140143 |
|---|---|
| Supplement number | S497 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | INTERCEPT(R) Blood Systerm for Platelets |
| Generic name | Preparation and storage of pathogen-reduced, blood components. |
| Applicant | Cerus Corporation |
| Product code | PJF |
| Received date | Mar 31, 2020 |
| Decision date | Nov 6, 2020 |
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: