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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.
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
1430 decision street
vista, CA 92081-8553
PMA NumberP910066
Supplement NumberS012
Date Received09/22/1998
Decision Date10/16/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name orthologic 1000-sc and 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 shows no visibly progressive signs of healing.