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Device | PROPEL MINI SINUS IMPLANT |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S018 |
Date Received | 09/25/2015 |
Decision Date | 03/23/2016 |
Product Code |
OWO |
Docket Number | 16M-1123 |
Notice Date | 04/12/2016 |
Advisory Committee |
Ear Nose & Throat |
Clinical Trials | NCT00840970
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the PROPEL Mini Sinus Implant is intended for use in patients >= 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. The PROPEL Mini Sinus Implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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