REALIZE ADJUSTABLE GASTRIC BAND
FDA premarket approval P070009/S004 · decided 2009-02-23
Approval details
- PMA number
- P070009
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2008-09-29
- Decision date
- 2009-02-23
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- 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.
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