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Device | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | DUSA PHARMACEUTICALS, INC. 25 UPTON DR. WILMINGTON, MA 01887 |
PMA Number | P990019 |
Supplement Number | S003 |
Date Received | 03/03/2005 |
Decision Date | 10/06/2005 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF AN ALTERNATE MANUFACTURING SITE LOCATED AT DUSA PHARMACEUTICALS, INC., WILMINGTON, MASSACHUSETTS. |