PMA P940010S010
- Device
- OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S010
- Product code
- MVG
- Decision date
- 2003-08-01
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
Current openFDA PMA Record#
- Device
- OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S010
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2003-08-01
- Decision code
- APPR
- Date received
- 2002-06-12
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.