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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 NameBIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantEBI, L.P.
PMA NumberP850022
Supplement NumberS014
Date Received04/23/2003
Decision Date05/23/2003
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional labeling to emphasize the proper use of the device electrodes.
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