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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.
 
DeviceSPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
DJO, LLC
1430 decision street
vista, CA 92081-8553
PMA NumberP910066
Supplement NumberS025
Date Received06/12/2008
Decision Date12/24/2008
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR UPGRADES TO THE OL1000 SINGLE COIL, SIZE 1 MODEL AND THE MICROPROCESSOR-CONTROLLER (CONTROL BOX) USED FOR THE OL1000 SINGLE COIL, SIZE 1 MODEL.
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