PMA P020021
- Device
- WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
- Applicant
- Cook Endoscopy
- PMA number
- P020021
- Product code
- MVG
- Decision date
- 2003-08-01
- Classification
- General, Plastic Surgery
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- APPROVAL FOR THE WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER, WHICH REQUESTED APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE INDICATION FOR USE FOR ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
Current openFDA PMA Record#
- Device
- WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
- Applicant
- Cook Endoscopy
- PMA number
- P020021
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2003-08-01
- Decision code
- APWD
- Date received
- 2002-05-31
- Approval order statement
- APPROVAL FOR THE WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER, WHICH REQUESTED APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE INDICATION FOR USE FOR ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.