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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
Applicant
INTERSECT ENT
1555 adams dr
menlo park, CA 94025
PMA NumberP100044
Supplement NumberS023
Date Received08/01/2016
Decision Date02/23/2017
Product Code OWO 
Docket Number 17M-1228
Notice Date 03/10/2017
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval of the PROPEL Contour Sinus Implant. This device is indicated for use in patients greater than or equal to 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids to the sinus mucosa. The PROPEL Contour Sinus Implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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