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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 2001
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantEBI ELECTRO BIOLOGY
PMA NumberP790002
Supplement NumberS022
Date Received04/08/2002
Decision Date08/13/2002
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for various hardware and software changes.
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