REALIZE ADJUSTABLE GASTRIC BAND
FDA premarket approval P070009/S011 · decided 2011-07-15
Approval details
- PMA number
- P070009
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2011-01-18
- Decision date
- 2011-07-15
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS.
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