PMA P000008S038

Device

LAP-BAND Adjustable Gastric Banding System

Applicant

Medtimo, Inc.

PMA number

P000008

Supplement

S038

Product code

LTI

Decision date

2017-03-23

Classification

Implant, Intragastric For Morbid Obesity

Generic name

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Approval order statement

Removal of the Ultrasonic Thickness Gauge (UTG) inspection step of the “shell” thickness of the band of the LAP-BAND Adjustable Gastric Banding System from the incoming product inspection protocol.

Summary

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