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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 OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namebone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP790005
Supplement NumberS041
Date Received06/24/1998
Decision Date07/24/1998
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
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 ofthe labeling to include the definitiono f 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. , "a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
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