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 the modified version of the blu-u(tm) blue light photodynamic therapy illuminator. The device, as modified, will be marketed under the trade name blu-u(tm) model 4170.
| Device | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | DUSA PHARMACEUTICALS, INC. |
| Date Received | 2000-03-20 |
| Decision Date | 2000-09-26 |
| PMA | P990019 |
| Supplement | S001 |
| 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 |