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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DevicePROPEL MINI SINUS IMPLANT
Classification Namedrug-eluting sinus stent
Generic Namedrug-eluting sinus stent
Applicant
INTERSECT ENT
1555 adams dr
menlo park, CA 94025
PMA NumberP100044
Supplement NumberS001
Date Received03/12/2012
Decision Date09/21/2012
Product Code
OWO[ Registered Establishments with OWO ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A SHORTENED VERSION OF THE DRUG-ELUTING SINUS STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROPEL MINI SINUS IMPLANT AND 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 MINI SINUS IMPLANT SEPARATES MUCOSAL TISSUES, PROVIDES STABILIZATION OF THE MIDDLE TURBINATE, PREVENTS OBSTRUCTION BY ADHESIONS, AND REDUCES EDEMA.
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