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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.
 
DeviceImplantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS043
Date Received10/31/2016
Decision Date11/17/2016
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to add the following contraindication to the labeling: Any surgical implantation procedure such as minimally invasive surgical-MIS procedures requiring the SpF® Spinal Fusion Stimulators cathodes to be disconnected from their corresponding leads prior to or during implantation since this may seriously compromise the electrical performance of the implantable stimulators cathodes to deliver a constant current to the fusion site as intended.
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