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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 ORTHOGEN(R)/OSTEOGEN(TM) IMPLANTABLE BONE GROWTH STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namebone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP790005
Supplement NumberS038
Date Received03/13/1996
Decision Date11/15/1996
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of the test analysis for the device from caribbean bioresearch laboratories and geneva laboratories to electro-biology, inc. , in guaynabo, puerto rico.
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