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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 BONE HEALING SYSTEM-MODEL 1026
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI ELECTRO BIOLOGY
PMA NumberP790002
Supplement NumberS021
Date Received11/30/1999
Decision Date12/29/1999
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 
Seven modifications to the model 1026. Addition of components to the printed wiring board, addition of a ferrite sleeve, change in the control unit and labeling changes.
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