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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.
 
DeviceMC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
Generic NameBone sonometer
Regulation Number892.1180
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP990016
Supplement NumberS001
Date Received10/12/2001
Decision Date11/08/2001
Reclassified Date08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A SOFTWARE UPDATE FROM V4.2.0 TO V4.2.1 AND A NEW PHANTOM (QA COUPLER).
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