Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NHB · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3620
Classification
FDA Product Code
NHB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 874.3620
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.