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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 SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
Classification Namedrug-eluting sinus stent
ApplicantINTERSECT ENT
PMA NumberP100044
Supplement NumberS010
Date Received06/25/2013
Decision Date08/13/2013
Product Code
OWO[ Registered Establishments with OWO ]
Advisory Committee Ear Nose & Throat
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the instructions for use (ifu) and labels that enhance the safety in the use of the propel and propel mini sinus implants.
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