WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
FDA premarket approval P020021 · decided 2003-08-01
Approval details
- PMA number
- P020021
- Trade name
- WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Cook Endoscopy
- Date received
- 2002-05-31
- Decision date
- 2003-08-01
- Days to decision
- 427 days
- Decision code
- APWD
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Winston-Salem, NC
- 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.
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510(k) clearances by this applicant
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| Instinct Plus Endoscopic Clipping Device (K192697) | Cook Endoscopy | 2020-03-05 |
| HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (K090183) | Cook Endoscopy | 2009-09-25 |
| ECHOTIP ULTRA ULTRASOUND NEEDLE (K083330) | Cook Endoscopy | 2009-02-06 |
| COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (K061937) | Cook Endoscopy | 2006-12-01 |