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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 NameBIO OSTEOGEN SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI, L.P.
PMA NumberP790002
Supplement NumberS027
Date Received08/11/2011
Decision Date09/07/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Replacement of an analog electrical isolation tester with a digital electronic isolation tester, and addition of a manual hand-soldering process as an alternative to the existing automatic soldering process.
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