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.
| Device Type ID | 1667 |
| Device Name | Drug-eluting Sinus Stent |
| Physical State | Resorbable Polymer Coated In Drug |
| Technical Method | Delivered Through The Nostril. |
| Target Area | Sinus |
| Review Panel | Ear Nose & Throat |
| 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 |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OWO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1667 |
| Device | Drug-eluting Sinus Stent |
| Product Code | OWO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 22 |
Stent | 5 |
Migration Or Expulsion Of Device | 5 |
Appropriate Term/Code Not Available | 2 |
| Total Device Problems | 34 |