RESHAPE INTEGRATED DUAL BALLOON SYSTEM
FDA premarket approval P140012 · decided 2015-07-28
Approval details
- PMA number
- P140012
- Trade name
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-07-01
- Decision date
- 2015-07-28
- Days to decision
- 392 days
- Decision code
- APWD
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM. THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM IS INDICATED FOR WEIGHT REDUCTION WHEN USED IN CONJUNCTION WITH DIET AND EXERCISE, IN OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF 30 40 KG/M2 AND ONE OR MORE OBESITY-RELATED COMORBID CONDITIONS. IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED WEIGHT REDUCTION WITH DIET AND EXERCISE ALONE.
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