|
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 | S004 |
Date Received | 08/22/2006 |
Decision Date | 09/21/2006 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF AN ALTERNATE MANUFACTURER FOR THE TIMER ASSEMBLY IN THE DEVICE. |