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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.
 
DeviceSPINAL-STIM(R)
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantOrthofix, Inc.
3451 Plano Pkwy.
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS014
Date Received03/03/1994
Decision Date09/19/1996
Reclassified Date05/18/2026
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
COMPANY PROVIDED FINAL DRAFT LABELING MODIFIED TO REFLECT THE LONG-TERM SUCCESS RATES FOR THE DEVICE. TRADE NAME:SPINAL-STIM
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