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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 NameBIO OSTEOGEN SYSTEM 204
Classification Namestimulator, bone growth, non-invasive
Generic Nameosteogenesis stimulator
ApplicantBIOMET SPINE & BONE HEALING TECHNOLOGIES
PMA NumberP790002
Date Received01/15/1979
Decision Date11/06/1979
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 80M-0057
Notice Date 04/25/1980
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S006 S008 
S009 S010 S011 S012 S013 S014 
S015 S016 S018 S019 S020 S021 
S022 S023 S025 S026 S027 S028 
S029 
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