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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.
 
DeviceSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
Generic NameStimulator, bone growth, non-invasive
ApplicantBIOVENTUS LLC
4721 EMPEROR BLVD SUITE 100
DURHAM, NC 27703
PMA NumberP900009
Date Received02/01/1990
Decision Date10/05/1994
Product Code LOF 
Docket Number 94M-0363
Notice Date 11/09/1994
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S037 S018 S012 S013 S022 S027 S028 S008 
S009 S010 S024 S007 S031 S030 S014 S015 S041 S006 S011 S036 
S039 S033 S038 S035 S016 S017 S020 S021 S023 S019 S032 S025 
S029 S046 S042 S043 S044 S047 S048 S049 
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