PMA P070009S008

Device: REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S008
Product code: LTI
Decision date: 2010-07-30
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL FOR A DEVICE CHANGE TO ADD A SILICONE ADHESIVE TO BOND THE STRAIN RELIEF SLEEVE AND THE LOCKING CONNECTOR COMPONENTS OF THE INJECTION PORT.

Current openFDA PMA Record#

Device: REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S008
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2010-07-30
Decision code: APPR
Date received: 2010-06-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DEVICE CHANGE TO ADD A SILICONE ADHESIVE TO BOND THE STRAIN RELIEF SLEEVE AND THE LOCKING CONNECTOR COMPONENTS OF THE INJECTION PORT.