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: Mometasone Furoate Container Closure System
• Generic Name: Drug-eluting sinus stent
• Applicant: Intersect Ent.; 1555 Adams Dr.; Menlo Park, CA 94025
• PMA Number: P100044
• Supplement Number: S030
• Date Received: 08/29/2017
• Decision Date: 09/27/2017
• Product Code: OWO
• Advisory Committee: Ear Nose & Throat
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Addition of automated sealing equipment to add aluminum seals to the mometasone furoate (MF) container closure system utilized to store drug in the manufacturing area.