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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-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
Generic NameStimulator, invasive bone growth
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS024
Date Received07/06/1998
Decision Date04/07/1999
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes stating the device was MR Safe.
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