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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACHILLES EXPRESS ULTRASONOMETER
Classification Namebone sonometer
Generic Nameultrasonometer
Regulation Number892.1180
ApplicantLUNAR
PMA NumberP970040
Supplement NumberS001
Date Received02/16/1999
Decision Date04/23/1999
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change that was primarily to replace the open water bath with water enclosed in silicone membranes. The device, as modified, will be marketed under the trade name achilles express and is indicated for: the achilles express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called stiffness index. The stiffness index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (bmd) as measured by x-ray absorptiometry at the spine or hip.
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