PMA P070009S013

Device: REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S013
Product code: LTI
Decision date: 2011-03-31
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL FOR A DEVICE CHANGE TO MODIFY THE SILICONE MATERIAL USED FOR THE INJECTION PORT SEPTUM AND INJECTION PORT CONNECTOR SLEEVE COMPONENTS, ALONG WITH A MINOR ASSOCIATED LABELING MODIFICATION.

Current openFDA PMA Record#

Device: REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S013
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: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DEVICE CHANGE TO MODIFY THE SILICONE MATERIAL USED FOR THE INJECTION PORT SEPTUM AND INJECTION PORT CONNECTOR SLEEVE COMPONENTS, ALONG WITH A MINOR ASSOCIATED LABELING MODIFICATION.