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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameKARL STORZ AUTOFLUORESCENCE SYSTEM
Classification Namesystem, imaging, fluorescence
Generic Namefluorescence system
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
PMA NumberP020008
Date Received03/07/2002
Decision Date12/12/2002
Product Code
MRK[ Registered Establishments with MRK ]
Docket Number 03M-0011
Notice Date 01/22/2003
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 
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