|
Device | REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | OBTECH MEDICAL GMBH LANDIS AND GYR STRASSE 1 ZUG CH-63-6300 |
PMA Number | P070009 |
Date Received | 04/02/2007 |
Decision Date | 09/28/2007 |
Withdrawal Date
|
03/17/2017 |
Product Code |
LTI |
Docket Number | 07M-0380 |
Notice Date | 11/09/2007 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE REALIZE ADJUSTABLE GASTRIC BAND. THIS DEVICE IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTS AND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OF AT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY IN MORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 |