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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 STIMULATORS
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantDjo, LLC
1430 Decision St.
Vista, CA 92081
PMA NumberP910066
Supplement NumberS028
Date Received01/19/2016
Decision Date02/18/2016
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the labeling to be in conformance with IEC 60601-1-6 ED.3.1, IEC 60601-1-2, ANSI/AAMI ES 60601-1:2005/A1:2012 and IEC 60601-11:2011.
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