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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 NumberS019
Date Received06/24/1998
Decision Date07/27/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of the indications and usage section of the labeling for models 1200, 1020-s, 1026, and 101, to include the definition of nonunion recommended by the orthopedic and rehabilitation devices panel on april 28, 1998 and required per fda's letter dated june 3, 1998 (i. E. , "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
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