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.
| Device | GARREN GASTRIC BUBBLE |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | AMERICAN EDWARDS LABORATORIES |
| Date Received | 1986-10-20 |
| Decision Date | 1987-03-17 |
| PMA | P840025 |
| Supplement | S011 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMERICAN EDWARDS LABORATORIES clayton Professional Bldg. suite 3a 118 North Street elkton, MD 21921-0000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840025 | Original Filing | |
| S011 | 1986-10-20 | Special (immediate Track) |
| S010 | ||
| S009 | ||
| S008 | 1986-08-08 | Normal 180 Day Track |
| S007 | ||
| S006 | 1986-05-14 | Normal 180 Day Track |
| S005 | 1986-03-27 | Normal 180 Day Track |
| S004 | 1985-12-16 | |
| S003 | 1985-11-29 | |
| S002 | 1985-11-04 | |
| S001 | 1985-10-28 |