REALIZE ADJUSTABLE GASTRIC BAND
FDA premarket approval P070009/S003 · decided 2008-10-15
Approval details
- PMA number
- P070009
- Supplement
- S003
- 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
- 2008-04-18
- Decision date
- 2008-10-15
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR A LINE EXTENSION TO THE REALIZE ADJUSTABLE GASTRIC BANDTHE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REALIZE ADJUSTABLE GASTRICBAND CURVED (MODEL BD3XV) AND IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTSAND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OFAT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY INMORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE
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