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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 NameOSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
ApplicantEBI, LLC
PMA NumberP790005
Supplement NumberS033
Date Received03/22/1989
Decision Date04/05/1990
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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