OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
FDA premarket approval P940010/S002 · decided 1998-01-09
Approval details
- PMA number
- P940010
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1997-02-10
- Decision date
- 1998-01-09
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated and approval to add a 2.0 cm diffuser to the DCYL Series of diffusers.
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