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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
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP790002
Supplement NumberS020
Date Received12/22/1998
Decision Date01/26/1999
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ebi bone healing system - model 2001, indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudoarthroses in the appendicular system.
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