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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 STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namebone growth stimulator
ApplicantBIOMET SPINE & BONE HEALING TECHNOLOGIES
PMA NumberP790005
Supplement NumberS048
Date Received12/21/2011
Decision Date01/20/2012
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of new in-process package seal strength tests.
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