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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePROPEL MINI SINUS IMPLANT
Classification Namedrug-eluting sinus stent
ApplicantINTERSECT ENT
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 - component
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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