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 a software change to eliminate the need to artificially limit the cycle lifetime for the blu-u treatment lamp system.
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 | 2011-06-27 |
Decision Date | 2011-07-07 |
PMA | P990019 |
Supplement | S007 |
Product Code | MVF |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | Yes |
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 |