This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Use of an alternate manufacturer for the timer assembly in the device.
| Device | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | DUSA PHARMACEUTICALS, INC. |
| Date Received | 2006-08-22 |
| Decision Date | 2006-09-21 |
| PMA | P990019 |
| Supplement | S004 |
| Product Code | MVF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DUSA PHARMACEUTICALS, INC. 25 Upton Dr. wilmington, MA 01887 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990019 | Original Filing | |
| S007 | 2011-06-27 | Real-time Process |
| S006 | 2008-12-10 | 30-day Notice |
| S005 | 2007-10-30 | Normal 180 Day Track No User Fee |
| S004 | 2006-08-22 | 30-day Notice |
| S003 | 2005-03-03 | Normal 180 Day Track No User Fee |
| S002 | 2002-09-30 | Normal 180 Day Track |
| S001 | 2000-03-20 | Normal 180 Day Track |