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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 NumberS008
Date Received12/30/1997
Decision Date06/12/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the indications for use language to state "the orthologic 1000 bone growth stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site show no visibly progressive sign s of healing"; and "the orthologic cc bone growth stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauam, ecxluding vertebrae and all flate bones. A nonunion is considred to be established when the fracture site shows no visibly progressive signs of healing. ".
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