Product code PFE

Device name

Gastrointestinal Liner System

Medical specialty

Unknown

Device class

N

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.

Source

FDA openFDA device classification dataset