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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.
 
DevicePROPEL
Classification Namedrug-eluting sinus stent
Generic Namedrug-eluting sinus stent
Applicant
INTERSECT ENT
1555 adams dr
menlo park, CA 94025
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
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: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S021 
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