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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 NumberS015
Date Received07/19/1994
Decision Date03/12/1998
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)-s coils (model numbers flx 2-s, flx 3-s, and flx 4-s) which will be used to deliver the single repetitive pulse (srp) signal produced by the ebi bone healing system(r) model 1020-s control unit. The device, as modified, will be marketed under the trade name ebi flx(r)-s coils and used with the ebi bone healing system(r) model 1020-s control unit which is indicated for the treatment of nonunions, failed fusions, and congenital pseudarthroses.
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