|
Device | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | Sun Pharmaceutical Industries, Inc. 29 Dunham Road Billerica, MA 01821 |
PMA Number | P990019 |
Supplement Number | S007 |
Date Received | 06/27/2011 |
Decision Date | 07/07/2011 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A SOFTWARE CHANGE TO ELIMINATE THE NEED TO ARTIFICIALLY LIMIT THE CYCLE LIFETIME FOR THE BLU-U TREATMENT LAMP SYSTEM. |