Premarket Approval (PMA)

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.

• Device: TOPS™ System
• Generic Name: Prosthesis, posterior spinal elements
• Applicant: Premia Spine, Ltd.; 7 Giborey Israel St.; Ramat Poleg; Netanya 4250407
• PMA Number: P220002
• Supplement Number: S001
• Date Received: 07/14/2023
• Decision Date: 08/11/2023
• Product Code: QWK
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.