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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantDJO, LLC
1430 DECISION STREET
VISTA, CA 92081-8553
PMA NumberP910066
Supplement NumberS022
Date Received08/31/2006
Decision Date10/13/2006
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED IN VISTA, CALIFORNIA.
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