|
Device | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170 |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | Sun Pharmaceutical Industries, Inc. 29 Dunham Road Billerica, MA 01821 |
PMA Number | P990019 |
Supplement Number | S005 |
Date Received | 10/30/2007 |
Decision Date | 10/10/2008 |
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 | Yes |
Approval Order Statement APPROVAL FOR THE NATIONAL BIOLOGICAL CORP., BEACHWOOD, OHIO FACILITY, FOR CONTRACT MANUFACTURING. |