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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 NameEBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namesdpf implantable spinal fusion stimulator
ApplicantBIOMET, INC.
PMA NumberP850035
Supplement NumberS032
Date Received07/17/2008
Decision Date08/15/2008
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a conformal coating adhesive to the electronic printed circuit boards of the device.
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