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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.
 
DeviceMCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
Generic NameBone sonometer
Regulation Number892.1180
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP990016
Supplement NumberS002
Date Received01/16/2002
Decision Date03/28/2002
Reclassified Date08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE CUBACLINICAL DATA CONTROLLER (DATA CONTROLLER). THE DATA CONTROLLER IS A HAND-HELD CONTROL DEVICE THAT ENABLES THE USER TO OPERATE THE CUBACLINICAL WITHOUT THE COMPUTER AND THE SOFTWARE FOR DATA ANALYSIS. THE MODIFICATIONS TO THE BONE SONOMETER CONSIST OF THE INTEGRATION OF THE DATA CONTROLLER AND ASSOCIATED SOFTWARE, SIMPLE REPLACEMENT OF THE CUBACLINICAL SERIAL CONNECTOR, AND DATA CONTROLLER OPERATING INSTRUCTIONS. THE RESULTS ARE DISPLAYED ON AN LCD SCREEN DISPLAY AND THE PRINTOUT SHOWS A GRAPHICAL DISPLAY OF PATIENT DATA.
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