Product Classification

• 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 Code: OWO
• Premarket Review: Division of Dental and ENT Devices (DHT1B); 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 Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible