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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTOPS™ System
Generic NameProsthesis, posterior spinal elements
ApplicantPremia Spine Ltd.
7 Giborey Israel Street
Ramat Poleg
Netanya 42504
PMA NumberP220002
Date Received02/16/2022
Decision Date06/15/2023
Product Code QWK 
Docket Number 23M-2945
Notice Date 07/21/2023
Advisory Committee Orthopedic
Clinical TrialsNCT01933607
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The TOPS System is a motion-preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The TOPS System is intended to stabilize the spine following a lumbar decompression without rigid fixation.The TOPS System is indicated for patients between 35 and 80 years of age with symptomatic degenerative spondylolisthesis up to Grade I, with moderate to severe lumbar spinal stenosis and either the thickening of the ligamentum flavum and/or of the scarring facet joint capsule at one level from L3 to L5.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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