PMA P990019S004
- Device
- BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
- Applicant
- Sun Pharmaceutical Industries, Inc.
- PMA number
- P990019
- Supplement
- S004
- Product code
- MVF
- Decision date
- 2006-09-21
- Classification
- System, Laser, Photodynamic Therapy
- Generic name
- System, laser, photodynamic therapy
- Approval order statement
- USE OF AN ALTERNATE MANUFACTURER FOR THE TIMER ASSEMBLY IN THE DEVICE.
Current openFDA PMA Record#
- Device
- BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
- Applicant
- Sun Pharmaceutical Industries, Inc.
- PMA number
- P990019
- Supplement
- S004
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2006-09-21
- Decision code
- OK30
- Date received
- 2006-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE MANUFACTURER FOR THE TIMER ASSEMBLY IN THE DEVICE.