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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 Contour Sinus Implant
Generic NameDrug-eluting sinus stent
ApplicantINTERSECT ENT
1555 ADAMS DR
MENLO PARK, CA 94025
PMA NumberP100044
Supplement NumberS037
Date Received11/30/2018
Decision Date02/28/2019
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
Approval Order Statement  
Approval for modifications to the design and manufacturing of the delivery system, including the implementation of mechanical press fit bond joints, new dimensional specifications, revisions to the tip molding process, and a redefined tensile strength specification for the applicator.
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