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U.S. Department of Health and Human Services

Product Classification

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Device drug-eluting sinus stent
Definition Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Physical State Resorbable polymer coated in drug
Technical Method Delivered through the nostril.
Target Area Sinus
Review Panel Ear Nose & Throat
Product CodeOWO
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible