KARL STORZ AUTOFLUORESCENCE SYSTEM
FDA premarket approval P020008 · decided 2002-12-12
Approval details
- PMA number
- P020008
- Trade name
- KARL STORZ AUTOFLUORESCENCE SYSTEM
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2002-03-07
- Decision date
- 2002-12-12
- Days to decision
- 280 days
- Decision code
- APWD
- Product code
- MRK
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Culver City, CA
- Statement
- APPROVAL FOR THE KARL STORZ AUTOFLUORESCENCE SYSTEM. THE KARL STORZ AUTOFLUORESCENCE SYSTEM IS INDICATED FOR USE IN WHITE LIGHT AND AUTOFLUORESCENCE BRONCHOSCOPY TO IDENTIFY AND LOCATE ABNORMAL BRONCHIAL TISSUE FOR BIOPSY AND HISTOLOGICAL EVALUATION. IT IS INDICATED IN PATIENTS WHO: 1) ARE SUSPECTED OF HAVING BRONCHOGENIC CARCINOMA AND ARE SCHEDULED FOR A BRONCHOSCOPY AS PART OF A STANDARD DIAGNOSTIC STAGING OR WORK-UP 2) HAVE BEEN PREVIOUSLY DIAGNOSED WITH LUNG CANCER AND WHO ARE AT HIGH RISK F
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