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

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: S018 S019 S013 S014 S016 S002 S001 S021 S023 S026 S028 ; S012 S015 S004 S005 S006 S007 S003 S010 S017 S008 S011 S024 ; S025 S020 S022 S027 S029 S034 S041 S042 S043 S044 S045 S046 ; S038 S039 S040 S051 S048 S030 S032 S031 S033 S035 S037 S036 ; S050 S049