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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 NumberS031
Date Received09/08/2017
Decision Date10/13/2017
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for labeling modifications to clarify instructions for an alternative implant loading method into the delivery system, and for appropriately orienting the delivery system distal tip for the specific sinus being treated.
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