PMA supplement
P860003 S102: Therakos CELLEX Photopheresis System
FDA PMA supplement · Normal 180 Day Track · Therakos Development Limited
Key facts
| Original PMA | P860003 |
|---|---|
| Supplement number | S102 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Therakos CELLEX Photopheresis System |
| Generic name | System, photopheresis, extracorporeal |
| Applicant | Therakos Development Limited |
| Product code | LNR |
| Received date | Feb 3, 2020 |
| Decision date | Jul 31, 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: