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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.
 
DeviceOSTEOSTIM(R)
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790005
Date Received01/31/1979
Decision Date01/25/1980
Product Code LOE 
Docket Number 80M-0254
Notice Date 07/18/1980
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements:  S001 S003 S004 S006 S007 S009 S010 S011 
S012 S013 S016 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 
S037 S038 S039 S040 S041 S042 S043 S044 S045 
S047 S048 S049 S050 S051 S052 S053 S054 S055 
S056 S057 S058 S059 S060 S061 S062 S063 S064 
S065 S066 
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