PMA P070009S011

Device: REALIZE ADJUSTABLE GASTRIC BAND
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S011
Product code: LTI
Decision date: 2011-07-15
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS.

Current openFDA PMA Record#

Device: REALIZE ADJUSTABLE GASTRIC BAND
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S011
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2011-07-15
Decision code: APPR
Date received: 2011-01-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS.