PMA P990019S001

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S001
Product code: MVF
Decision date: 2000-09-26
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR THE MODIFIED VERSION OF THE BLU-U(TM) BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BLU-U(TM) MODEL 4170.

Current openFDA PMA Record#

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S001
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2000-09-26
Decision code: APPR
Date received: 2000-03-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODIFIED VERSION OF THE BLU-U(TM) BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BLU-U(TM) MODEL 4170.