REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
FDA premarket approval P070009 · decided 2007-09-28
Approval details
- PMA number
- P070009
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2007-04-02
- Decision date
- 2007-09-28
- Days to decision
- 179 days
- Decision code
- APWD
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR THE REALIZE ADJUSTABLE GASTRIC BAND. THIS DEVICE IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTS AND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OF AT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY IN MORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.
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