PMA supplement
P990019 S006: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
FDA PMA supplement · 30-Day Notice · Sun Pharmaceutical Industries, Inc.
Key facts
| Original PMA | P990019 |
|---|---|
| Supplement number | S006 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Generic name | System, laser, photodynamic therapy |
| Applicant | Sun Pharmaceutical Industries, Inc. |
| Product code | MVF |
| Received date | Dec 10, 2008 |
| Decision date | Jan 9, 2009 |
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: