OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
FDA premarket approval P940010/S004 · decided 1998-12-23
Approval details
- PMA number
- P940010
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1998-03-24
- Decision date
- 1998-12-23
- Days to decision
- 274 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 reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
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