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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 NameSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantBIOVENTUS LLC
PMA NumberP900009
Date Received02/01/1990
Decision Date10/05/1994
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 94M-0363
Notice Date 11/09/1994
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S027 S028 S029 S030 
S031 S032 S033 S035 S036 S037 S038 S039 
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