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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 NameOL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namespinalogic 1000 bone growth stimulator
ApplicantDJ ORTHOPEDICS, LLC
PMA NumberP910066
Supplement NumberS020
Date Received09/03/2004
Decision Date04/13/2005
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at dj orthopedics, llc, vista, california.
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