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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 OSTEOGEN IMPLANTABLE GROWTH STIMULATOR AND EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS030
Date Received06/09/2004
Decision Date06/03/2005
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFIED, SMALLER VERSION OF THE DEVICES.
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