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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 a Highridge Medical Company
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS016
Date Received06/02/1995
Decision Date04/09/1996
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
Approval Order Statement  
CHANGES TO LABELING INCLUDING THE ADDITION OF INFORMATION REGARDING "TREATMENT COMPLETION," (AFFECTS PHYSICIAN INSTRUCTION MANUAL), A DESCRIPTION OF THE PMA POPULATION AND ORIGINAL AND FOUR YEAR SUCCESS RATES (AFFECTS PHYSICIAN INSTRUCTION AND PATIENT MANUALS) AND THE ADDITION OF A CONTRAINDICATION FOR PATEINTS WEARING IMPALNTABLE DEFIBRILLATORS (AFFECTS PHYSICIAN INSTRUCTION MANUAL)
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