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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceKARL STORZ AUTOFLUORESCENCE SYSTEM
Generic NameSYSTEM, IMAGING, FLUORESCENCE
ApplicantKARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City, CA 90230
PMA NumberP020008
Supplement NumberS002
Date Received10/22/2009
Decision Date12/23/2009
Withdrawal Date08/28/2019
Product Code MRK 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REPLACEMENT OF THE KARL STORZ CAMERA CONTROL UNIT (CCU), TRICAM SL (ANALOG PROCESSING) WITH THE TRICAM SL II (DIGITAL SIGNAL PROCESSING).
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