PMA P000008S040

Device

LAP-BAND Adjustable Gastric Banding System

Applicant

Medtimo, Inc.

PMA number

P000008

Supplement

S040

Product code

LTI

Decision date

2018-01-16

Classification

Implant, Intragastric For Morbid Obesity

Generic name

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Approval order statement

Changes to the adhesive strip tolerance limits and an additional cavity in the Outer Tray Sealing Nest Tool.

Summary

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