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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS020
Date Received08/25/1997
Decision Date03/09/2000
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the device labeling to include patient registry data in addition to the original data contained in the pma.
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