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 trade name changes from realize adjustable gastric band-c with injection port and applier to ethicon endo-surgery curved adjustable gastric band with sutureless port and applier, and realize injection port and applier to ethicon endo-surgery gastric band sutureless port and applier.
| Device | Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | OBTECH MEDICAL GMBH |
| Date Received | 2016-04-21 |
| Decision Date | 2016-05-16 |
| PMA | P070009 |
| Supplement | S016 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |