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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
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
Orthofix, Inc.
3451 plano parkway
lewisville, TX 75056
PMA NumberP850007
Supplement NumberS006
Date Received06/06/1988
Decision Date02/07/1990
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 90M-0067
Notice Date 03/08/1990
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
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