This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | OBTECH MEDICAL GMBH |
| Date Received | 2007-04-02 |
| Decision Date | 2007-09-28 |
| Notice Date | 2007-11-09 |
| PMA | P070009 |
| Supplement | S |
| Product Code | LTI |
| Docket Number | 07M-0380 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OBTECH MEDICAL GMBH landis And Gyr Strasse 1 zug CH-63-6300 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070009 | Original Filing | |
| S017 | 2016-06-21 | Normal 180 Day Track No User Fee |
| S016 | 2016-04-21 | Normal 180 Day Track No User Fee |
| S015 | 2015-03-09 | 30-day Notice |
| S014 | 2011-11-04 | 30-day Notice |
| S013 | 2011-02-08 | Real-time Process |
| S012 | 2011-02-08 | 135 Review Track For 30-day Notice |
| S011 | 2011-01-18 | Normal 180 Day Track |
| S010 | 2010-06-29 | 30-day Notice |
| S009 | 2010-05-07 | Special (immediate Track) |
| S008 | 2010-06-07 | Real-time Process |
| S007 | 2009-12-22 | 135 Review Track For 30-day Notice |
| S006 | 2009-09-08 | 30-day Notice |
| S005 | 2009-07-29 | 30-day Notice |
| S004 | 2008-09-29 | 135 Review Track For 30-day Notice |
| S003 | 2008-04-18 | Normal 180 Day Track |
| S002 | 2008-03-13 | 30-day Notice |
| S001 | 2007-10-29 | Normal 180 Day Track No User Fee |