OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM
FDA premarket approval P940010/S009 · decided 2000-09-29
Approval details
- PMA number
- P940010
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2000-04-17
- Decision date
- 2000-09-29
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR MODIFICATION OF THE OPTIGUIDE FIBER OPTIC DIFFUSE TO INCLUDE USE OF A STERILE, SINGLE USE SHEATH WITH A REUSABLE DIFFUSING FIBER OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM, SERIES DCYL 4 AND IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN(R) (PORFIMER SODIUM) FOR INJECTION FOR THE: 1) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OB
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