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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePropel Sinus Implant & Propel mini Sinus Implant
Generic NameDrug-eluting sinus stent
ApplicantIntersect Ent.
1555 Adams Dr.
Menlo Park, CA 94025
PMA NumberP100044
Supplement NumberS027
Date Received03/01/2017
Decision Date05/30/2017
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of mechanically interlocking bond joints for the Propel and Propel Mini delivery systems, as well as a redefined tensile strength specification for the Propel applicator.
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