PMA - Premarket Approval

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New Search Back to Search Results 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 Name EBI BONE HEALING SYSTEM-MODEL 1026 Classification Name stimulator, bone growth, non-invasive Generic Name bone growth stimulator Applicant EBI ELECTRO BIOLOGY PMA Number P790002 Supplement Number S021 Date Received 11/30/1999 Decision Date 12/29/1999 Product Code LOF [ Registered Establishments with LOF ] Advisory Committee Orthopedic Supplement Type real-time process Supplement Reason design change - minor Expedited Review Granted? 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.