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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 BONE HEALING SYSTEM(R)
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS015
Date Received07/19/1994
Decision Date03/12/1998
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the FLX(R)-S Coils (model numbers FLX 2-S, FLX 3-S, and FLX 4-S) which will be used to deliver the single repetitive pulse (SRP) signal produced by the EBI Bone Healing System(R) Model 1020-S control unit. The device, as modified, will be marketed under the trade name EBI FLX(R)-S Coils and used with the EBI Bone Healing System(R) Model 1020-S control unit which is indicated for the treatment of nonunions, failed fusions, and congenital pseudarthroses.
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