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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 NameOL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namespinalogic 1000 bone growth stimulator
ApplicantORTHOLOGIC CORP.
PMA NumberP910066
Supplement NumberS017
Date Received12/20/2002
Decision Date08/01/2003
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for various labeling, software and hardware changes.
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