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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 Family of Sinus Implants
Generic NameDrug-eluting sinus stent
ApplicantINTERSECT ENT
1555 ADAMS DR
MENLO PARK, CA 94025
PMA NumberP100044
Supplement NumberS036
Date Received10/12/2018
Decision Date01/10/2019
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for extending the storage shelf life of the component fibers used in the manufacture of the Propel Family of Sinus Implants (Propel, Propel Mini, Propel Contour) to 20 months.
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