|
Device | LAP-BAND |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92672 |
PMA Number | P000008 |
Supplement Number | S017 |
Date Received | 04/27/2010 |
Decision Date | 02/16/2011 |
Product Code |
LTI |
Docket Number | 12M-1013 |
Notice Date | 09/26/2012 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00570505
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM. THE LAP-BAND SYSTEM IS INDICATED FOR WEIGHT REDUCTION FOR PATIENTS WITH OBESITY, WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2 OR A BMI OF AT LEAST 30 KG/ M2 WITH ONE OR MORE OBESITY RELATED COMORBID CONDITIONS. IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. PATIENTS WHO ELECT TO HAVE THIS SURGERY MUST MAKE THE COMMITMENT TO ACCEPT SIGNIFICANT CHANGES IN THEIR EATING HABITS FOR THE REST OF THEIR LIVES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |