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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 NameBIOMET EBI BONE HEALING
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI, LLC
PMA NumberP790002
Supplement NumberS031
Date Received02/07/2014
Decision Date04/30/2014
Product Code
LOF
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the software to prevent a cannot treat error.
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