PFE — Gastrointestinal Liner System Class N

FDA Device Classification

FDA product code PFE covers "Gastrointestinal Liner System", a Class N medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
PFE
Device Class
Class N
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
Yes

Definition

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