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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 NumberS018
Date Received02/10/1997
Decision Date06/11/1997
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the flx(r) coilette which will be used to delivery the approved repetitive pulse burst signal produced by the ebi bone healing system model 1200. The device, as modified, will be marketed under the trade name ebi flx coilette to be used with the ebi bone healing system model 1200 which is indicated for nonunions, failed fusions, and congenital pseudarthroses.
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