PMA P070009S012

Device: REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S012
Product code: LTI
Decision date: 2011-03-31
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE INJECTION MOLDING OF THE SEPTUM AND CONNECTOR SLEEVE COMPONENTS OF THE INJECTION PORT.

Current openFDA PMA Record#

Device: REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S012
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2011-03-31
Decision code: APPR
Date received: 2011-02-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE INJECTION MOLDING OF THE SEPTUM AND CONNECTOR SLEEVE COMPONENTS OF THE INJECTION PORT.