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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.
 
DeviceORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantDJO, LLC
1430 DECISION STREET
VISTA, CA 92081-8553
PMA NumberP910066
Date Received11/18/1991
Decision Date03/04/1994
Product Code LOF 
Docket Number 94M-0128
Notice Date 05/20/1994
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S004 S005 S007 S008 S009 S011 S012 S013 S014 S015 
S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 
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