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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 SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI, L.P.
PMA NumberP790002
Supplement NumberS026
Date Received06/29/2010
Decision Date05/19/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified, redesigned, noninvasive pulsed electromagnetic field bone growth stimulator system that uses new sflx coils.
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