PMA P070009S004

Device: REALIZE ADJUSTABLE GASTRIC BAND
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S004
Product code: LTI
Decision date: 2009-02-23
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL TO MODIFY THE INJECTION PORT TORQUE INSPECTION PROCEDURE BY REPLACING PRE-AND POST-TORQUE TEST INSPECTIONS WITH VISUAL AND FUNCTIONAL INSPECTIONS AND MODIFY THREE INJECTION PORT MANUFACTURING DOCUMENTS TO INCORPORATE THE CHANGES IN THE TORQUE INSPECTION PROCEDURE AND TO IMPROVE CLARITY OF INSTRUCTIONS.

Current openFDA PMA Record#

Device: REALIZE ADJUSTABLE GASTRIC BAND
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S004
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2009-02-23
Decision code: APPR
Date received: 2008-09-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO MODIFY THE INJECTION PORT TORQUE INSPECTION PROCEDURE BY REPLACING PRE-AND POST-TORQUE TEST INSPECTIONS WITH VISUAL AND FUNCTIONAL INSPECTIONS AND MODIFY THREE INJECTION PORT MANUFACTURING DOCUMENTS TO INCORPORATE THE CHANGES IN THE TORQUE INSPECTION PROCEDURE AND TO IMPROVE CLARITY OF INSTRUCTIONS.