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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 AND PROPEL MINI SINUS IMPLANT
Classification Namedrug-eluting sinus stent
ApplicantINTERSECT ENT
PMA NumberP100044
Supplement NumberS007
Date Received01/29/2013
Decision Date02/27/2013
Product Code
OWO[ Registered Establishments with OWO ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to two quality control test methods.
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