| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | KARL STORZ AUTOFLUORESCENCE SYSTEM |
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| Generic Name | SYSTEM, IMAGING, FLUORESCENCE |
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| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 |
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| PMA Number | P020008 |
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| Date Received | 03/07/2002 |
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| Decision Date | 12/12/2002 |
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Withdrawal Date
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08/28/2019 |
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| Product Code |
MRK |
| Docket Number | 03M-0011 |
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| Notice Date | 01/22/2003 |
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| Advisory Committee |
Ear Nose & Throat |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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 FOR RECURRENCE 3) HAVE ABNORMAL SPUTUM CYTOLOGY 4) HAVE ABNORMAL CHEST X-RAY, CT SCAN OR SIMILAR TECHNOLOGY. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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