This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a line extension to the realize adjustable gastric bandthe device, as modified, will be marketed under the trade name realize adjustable gastricband curved (model bd3xv) and is indicated for weight reduction for morbidly obese patientsand is indicated for individuals with a body mass index (bmi) of at least 40 kg/m2, or a bmi ofat least 35 kg/m2 with one or more comorbid conditions. The band is indicated for use only inmorbidly 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 |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | OBTECH MEDICAL GMBH |
| Date Received | 2008-04-18 |
| Decision Date | 2008-10-15 |
| PMA | P070009 |
| Supplement | S003 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OBTECH MEDICAL GMBH landis And Gyr Strasse 1 zug CH-63-6300 |
| 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 |