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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 |
Date Received | 03/16/1999 |
Decision Date | 12/03/1999 |
Product Code |
MVF |
Docket Number | 00M-1613 |
Notice Date | 11/14/2000 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement The devices is indicated for use in Photodynamic Therapy with Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 |