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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 AUTOFLURESCENCE SYSTEM
Generic NameSYSTEM, IMAGING, FLUORESCENCE
ApplicantKARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City, CA 90230
PMA NumberP020008
Supplement NumberS001
Date Received02/07/2005
Decision Date03/04/2005
Withdrawal Date08/28/2019
Product Code MRK 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE OEM SENSOR FOR THE KARL STORZ AUTOFLUORESCENCE SYSTEM.
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