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: X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
• Generic Name: Prosthesis, spinous process spacer/plate
• Applicant: Medtronic Sofamor Danek, Inc.; 1800 Pyramid Pl.; Memphis, TN 38132
• PMA Number: P040001
• Supplement Number: S001
• Date Received: 01/23/2006
• Decision Date: 12/08/2006
• Withdrawal Date: 04/30/2015
• Product Code: NQO
• 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 POST-APPROVAL STUDY.