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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 
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