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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.
 
DevicePHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS026
Date Received02/01/2001
Decision Date03/09/2001
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHOFIX, INC., MCKINNEY, TEXAS.
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