• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible