Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PROPEL
• Generic Name: Drug-eluting sinus stent
• Applicant: Intersect Ent.; 1555 Adams Dr.; Menlo Park, CA 94025
• PMA Number: P100044
• Date Received: 12/06/2010
• Decision Date: 08/11/2011
• Product Code: OWO
• Docket Number: 11M-0600
• Notice Date: 08/19/2011
• Advisory Committee: Ear Nose & Throat
• Clinical Trials: NCT00840970
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE PROPEL SINUS IMPLANT. THIS DEVICE IS INDICATED FOR USE IN PATIENTS >= 18 YEARS OF AGE FOLLOWING ETHMOID SINUS SURGERY TO MAINTAIN PATENCY, THEREBY REDUCING THE NEED FOR POST-OPERATIVE INTERVENTION SUCH AS SURGICAL ADHESION LYSIS AND/OR USE OF ORAL STEROIDS. THE PROPEL SINUS IMPLANT SEPARATES MUCOSAL TISSUES, PROVIDES STABILIZATION OF THE MIDDLE TURBINATE, PREVENTS OBSTRUCTION BY ADHESIONS, AND REDUCES EDEMA.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S004 S005 S006 S007 S021 S022 S027 S020 S023 S028 S029 ; S026 S024 S025 S034 S030 S031 S042 S045 S046 S048 S050 S052 ; S053 S054 S033 S032 S035 S036 S043 S044 S058 S057 S056 S059 ; S003 S012 S013 S014 S017 S008 S015 S018 S019 S002 S016 S037 ; S038 S039 S040 S041 S011 S001 S049 S051 S010 S055