Drug-Eluting Sinus Stent
The Drug-Eluting Sinus Stent is a device designed to mechanically maintain patency following ethmoid sinus surgery while also eluting drugs to reduce the need for post-operative interventions such as surgical adhesion lysis or use of oral steroids. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to its high-risk combination of mechanical and drug-delivery functions. The product code is OWO, with an implant flag indicating it is placed within the body; it is reviewed under the ear, nose, and throat (ENT) panel.
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Basic Information
- Product Code
- OWO
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.