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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
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS012
Date Received08/07/1989
Decision Date12/13/1989
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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