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 CONTOUR SINUS IMPLANT
• Generic Name: Drug-eluting sinus stent
• Applicant: INTERSECT ENT; 1555 ADAMS DR; MENLO PARK, CA 94025
• PMA Number: P100044
• Supplement Number: S023
• Date Received: 08/01/2016
• Decision Date: 02/23/2017
• Product Code: OWO
• Docket Number: 17M-1228
• Notice Date: 03/10/2017
• Advisory Committee: Ear Nose & Throat
• Clinical Trials: NCT00840970
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval of the PROPEL Contour Sinus Implant. This device is indicated for use in patients greater than or equal to 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids to the sinus mucosa. The PROPEL Contour Sinus Implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. 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