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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.
 
DeviceAME BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantOrthofix, Inc.
3451 Plano Pkwy.
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS006
Date Received06/06/1988
Decision Date02/07/1990
Reclassified Date05/18/2026
Product Code LOF 
Docket Number 90M-0067
Notice Date 03/08/1990
Advisory Committee Orthopedic
Supplement TypePanel Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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