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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOSTEOSTIM(R)
Classification Namestimulator, invasive bone growth
Generic Nameinvasive ostengenesis stimulator
ApplicantEBI, L.P.
PMA NumberP790005
Date Received01/31/1979
Decision Date01/25/1980
Product Code
LOE[ Registered Establishments with LOE ]
Docket Number 80M-0254
Notice Date 07/18/1980
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
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 
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