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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROPEL
Classification Namedrug-eluting sinus stent
ApplicantINTERSECT ENT
PMA NumberP100044
Date Received12/06/2010
Decision Date08/11/2011
Product Code
OWO[ Registered Establishments with OWO ]
Docket Number 11M-0600
Notice Date 08/19/2011
Advisory Committee Ear Nose & Throat
Clinical Trials NCT00840970
NCT00912405
NCT01253577
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S005 S007 
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