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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.
 
DeviceHOLOGIC SAHARA CLINICAL BONE SONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP970017
Supplement NumberS001
Date Received11/12/1998
Decision Date04/29/1999
Reclassified Date08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in the manufacturing site to 35 Crosby Dr., Bedford, MA 01730.
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