PMA P000008S028

Device

LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Applicant

Medtimo, Inc.

PMA number

P000008

Supplement

S028

Product code

LTI

Decision date

2014-10-07

Classification

Implant, Intragastric For Morbid Obesity

Generic name

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Approval order statement

APPROVAL FOR DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT, DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT APPLIER, AND PACKAGING CHANGES.

Summary

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