Product code OWO

Device name

Drug-Eluting Sinus Stent

Medical specialty

Unknown

Device class

3

Review panel

EN

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset