PMA P990019S002
- Device
- BLU-U
- Applicant
- Sun Pharmaceutical Industries, Inc.
- PMA number
- P990019
- Supplement
- S002
- Product code
- MVF
- Decision date
- 2003-01-09
- Classification
- System, Laser, Photodynamic Therapy
- Generic name
- System, laser, photodynamic therapy
- Approval order statement
- APPROVAL FOR EXTENSION OF THE CALIBRATION INTERVAL FROM THE CURRENTLY APPROVED 500 CYCLES (WITH A 50 CYCLE BUFFER) TO 1600 CYCLES (WITH A 50 CYCLE BUFFER).
Current openFDA PMA Record#
- Device
- BLU-U
- Applicant
- Sun Pharmaceutical Industries, Inc.
- PMA number
- P990019
- Supplement
- S002
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2003-01-09
- Decision code
- APPR
- Date received
- 2002-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXTENSION OF THE CALIBRATION INTERVAL FROM THE CURRENTLY APPROVED 500 CYCLES (WITH A 50 CYCLE BUFFER) TO 1600 CYCLES (WITH A 50 CYCLE BUFFER).