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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBIO OSTEOGEN SYSTEM 204
Generic NameStimulator, bone growth, non-invasive
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP790002
Date Received01/15/1979
Decision Date11/06/1979
Product Code LOF 
Docket Number 80M-0057
Notice Date 04/25/1980
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S006 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S018 S019 S020 S021 S022 S023 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
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