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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(R)
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP790002
Supplement NumberS016
Date Received06/02/1995
Decision Date04/09/1996
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to labeling including the addition of information regarding "treatment completion," (affects physician instruction manual), a description of the pma population and original and four year success rates (affects physician instruction and patient manuals) and the addition of a contraindication for pateints wearing impalntable defibrillators (affects physician instruction manual).
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