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: S029
• Date Received: 12/08/2022
• Decision Date: 01/06/2023
• Product Code: NQO
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Introduce an additional cleanroom facility at your Clonmel Ireland manufacturing facility.