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: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Generic Name: Prosthesis, spinous process spacer/plate
• Applicant: Boston Scientific Neuromodulation; 25155 Rye Canyon Loop; Valencia, CA 91355
• PMA Number: P140004
• Supplement Number: S006
• Date Received: 01/05/2017
• Decision Date: 12/28/2017
• Product Code: NQO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approved for site change.