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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, 6011
Classification Namedrug-eluting sinus stent
ApplicantINTERSECT ENT
PMA NumberP100044
Supplement NumberS003
Date Received10/05/2012
Decision Date11/09/2012
Product Code
OWO[ Registered Establishments with OWO ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the stent crimper and delivery system accessory components of the device.
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