PMA supplement
P860003 S073: THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY
FDA PMA supplement · 30-Day Notice · Therakos Development Limited
Key facts
| Original PMA | P860003 |
|---|---|
| Supplement number | S073 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY |
| Generic name | System, photopheresis, extracorporeal |
| Applicant | Therakos Development Limited |
| Product code | LNR |
| Received date | Apr 9, 2013 |
| Decision date | May 6, 2013 |
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: