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: PROPEL MINI SINUS IMPLANT
• Generic Name: Drug-eluting sinus stent
• Applicant: INTERSECT ENT; 1555 ADAMS DR; MENLO PARK, CA 94025
• PMA Number: P100044
• Supplement Number: S018
• Date Received: 09/25/2015
• Decision Date: 03/23/2016
• Product Code: OWO
• Docket Number: 16M-1123
• Notice Date: 04/12/2016
• Advisory Committee: Ear Nose & Throat
• Clinical Trials: NCT00840970
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for the PROPEL Mini Sinus Implant is intended for use in patients >= 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. The PROPEL Mini Sinus Implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling