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Device | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92672 |
PMA Number | P000008 |
Date Received | 02/09/2000 |
Decision Date | 06/05/2001 |
Product Code |
LTI |
Docket Number | 02M-0250 |
Notice Date | 06/03/2002 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LAP-BAND. ADJUSTABLE GASTRIC BANDING (LAGB.) SYSTEM. THE DEVICE IS INDICATED FOR USE IN WEIGHT REDUCTION FOR SEVERELY OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 OR A BMI OF AT LEAST 35 WITH ONE OR MORE SEVERE COMORBID CONDITIONS, OR THOSE WHO ARE 100 LBS. OR MORE OVER THEIR ESTIMATED IDEAL WEIGHT ACCORDING TO THE 1983 METROPOLITAN LIFE INSURANCE TABLES (USE THE MIDPOINT FOR MEDIUM FRAME). IT IS INDICATED FOR USE ONLY IN SEVERELY OBESE 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
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
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