PMA P990019S007

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S007
Product code: MVF
Decision date: 2011-07-07
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
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.

Current openFDA PMA Record#

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S007
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2011-07-07
Decision code: APPR
Date received: 2011-06-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.