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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.
 
DeviceEBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS032
Date Received07/17/2008
Decision Date08/15/2008
Product Code LOE 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A CONFORMAL COATING ADHESIVE TO THE ELECTRONIC PRINTED CIRCUIT BOARDS OF THE DEVICE.
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