PMA
P860003: UVAR PHOTOPHERESIS SYSTEM
FDA PMA · System, photopheresis, extracorporeal · Therakos Development Limited
Key facts
| PMA number | P860003 |
|---|---|
| Trade name | UVAR PHOTOPHERESIS SYSTEM |
| Generic name | System, photopheresis, extracorporeal |
| Applicant | Therakos Development Limited |
| Owner/operator | Therakos Development Limited |
| Product code | LNR |
| Approval date | Apr 8, 1987 |
| Docket number | 87M-0136 |
| Notice date | May 18, 1987 |
| Establishment registration | 3036773437 |
| FEI number | 3036773437 |
At a glance
- 100–999 Supplements
- Nov 21, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: