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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 1000-SC BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namespinalogic 1000 bone growth stimulator
ApplicantORTHOLOGIC CORP.
PMA NumberP910066
Supplement NumberS014
Date Received02/15/2000
Decision Date03/09/2000
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the physician manual and package insert, and the patient manual.
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