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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.
 
DeviceOL1000/OL1000 SC/SPINALOGIC 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 NumberS016
Date Received04/11/2001
Decision Date05/18/2001
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to: 1)reformat the patient manuals for the ol 1000 and ol 1000 sc bone growth stimulators per the recent cdrh guidance on medical device labeling, 2) reformat the patient manual for the spinalogic(tm) bone growth stimulator per the recent cdrh guidance on medical device labeling.
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