|
Device | RESHAPE INTEGRATED DUAL BALLOON SYSTEM |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140012 |
Date Received | 07/01/2014 |
Decision Date | 07/28/2015 |
Withdrawal Date | 07/23/2019 |
Product Code |
LTI |
Docket Number | 15M-2740 |
Notice Date | 07/29/2015 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01061385
|
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Approval Order 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S012 S011 S010 S008 S005 S001 S002 S003 S004 S006 S007 S009 S013 |