OWO · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OWO
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
EN
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.