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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: S036  S039 S007 S008 S009 S010 S011 S012 S013 S014 S015 
S016 S017 S020 S021 S022 S023 S024 S025 S027 S028 S029 S031 
S032 S041 S042 S043 S044 S046 S047 S048 S030 S018 S019 S006 
S038 S037 S035 S033 S002 S003 S001 
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