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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOMET BHS- MINI
Generic NameStimulator, bone growth, non-invasive
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS025
Date Received04/06/2007
Decision Date01/17/2008
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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