OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC
FDA premarket approval P940010/S005 · decided 1998-11-23
Approval details
- PMA number
- P940010
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1998-08-21
- Decision date
- 1998-11-23
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for commerical distributing of the modified DCYL Cylindrical Fiber Optics which incorporate a glued diffusing tip in place of the previously approved threaded tip. The device, as modified, will be marketed under the trade name OPTIGUIDE Cylindrical Fiber Optic (DCYL2 Diffuser Series and is indicated for: palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinon of their physician, cannot be satisf
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