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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 NameORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantORTHOLOGIC CORP.
PMA NumberP910066
Supplement NumberS002
Date Received02/20/1996
Decision Date01/03/1997
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change for the device to reference the results of an expanded patient data registry for patients treated with the device during the first two years of marketing for the approved indication.
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