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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 BHS- MINI
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantBIOMET, INC.
PMA NumberP790002
Supplement NumberS025
Date Received04/06/2007
Decision Date01/17/2008
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications related to two new coils, a new battery type, a new coil application method, and a redesigned control box. The device, as modified, will be marketed under the trade name biomet bhs-mini and is indicated for the treatment of fracture non-unions, failed fusions, and congenital pseudoarthrosis in the appendicular system.
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