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.
Approval for extension of the calibration interval from the currently approved 500 cycles (with a 50 cycle buffer) to 1600 cycles (with a 50 cycle buffer).
| Device | BLU-U |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | DUSA PHARMACEUTICALS, INC. |
| Date Received | 2002-09-30 |
| Decision Date | 2003-01-09 |
| PMA | P990019 |
| Supplement | S002 |
| Product Code | MVF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |