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 the use of an alternate supplier for the injection molding of the septum and connector sleeve components of the injection port.
| Device | REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | OBTECH MEDICAL GMBH |
| Date Received | 2011-02-08 |
| Decision Date | 2011-03-31 |
| PMA | P070009 |
| Supplement | S012 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |