PMA P990019S005

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S005
Product code: MVF
Decision date: 2008-10-10
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR THE NATIONAL BIOLOGICAL CORP., BEACHWOOD, OHIO FACILITY, FOR CONTRACT MANUFACTURING.

Current openFDA PMA Record#

Device: BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170
Applicant: Sun Pharmaceutical Industries, Inc.
PMA number: P990019
Supplement: S005
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2008-10-10
Decision code: APPR
Date received: 2007-10-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE NATIONAL BIOLOGICAL CORP., BEACHWOOD, OHIO FACILITY, FOR CONTRACT MANUFACTURING.