Product code NYT

Device name

Prosthesis, Tracheal, Expandable, Polymeric

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.3720

Review panel

SU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.

Source

FDA openFDA device classification dataset