PMA P990019S003

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S003
Product code: MVF
Decision date: 2005-10-06
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL OF AN ALTERNATE MANUFACTURING SITE LOCATED AT DUSA PHARMACEUTICALS, INC., WILMINGTON, MASSACHUSETTS.

Current openFDA PMA Record#

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S003
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2005-10-06
Decision code: APPR
Date received: 2005-03-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL OF AN ALTERNATE MANUFACTURING SITE LOCATED AT DUSA PHARMACEUTICALS, INC., WILMINGTON, MASSACHUSETTS.