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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.
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
399 jefferson road
parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS015
Date Received07/19/1994
Decision Date03/12/1998
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.