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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 NameEBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS
Classification Namestimulator, invasive bone growth
Generic Namebone growth stimulator
ApplicantBIOMET SPINE AND BONE GROWTH TECHNOLOGIES D.B.A EBI, LLC
PMA NumberP790005
Supplement NumberS051
Date Received08/20/2014
Decision Date09/19/2014
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional of an alternate component supplier.
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