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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.
 
DeviceTOPS™ System
Generic NameProsthesis, posterior spinal elements
ApplicantPremia Spine, Ltd.
7 Giborey Israel St.
Ramat Poleg
Netanya 4250407
PMA NumberP220002
Supplement NumberS003
Date Received09/28/2023
Decision Date10/27/2023
Product Code QWK 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to introduce a semi-automated machine for the insertion of the Polycarbonate Urethane (PcU) Plug, adjustment to the Leak Detection Machine and change to the pedicle screw body surface blasting of the TOPS™ System.
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