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 | ANGELCHIK ANTI-REFLUX PROSTHESIS |
| Generic Name | Implant, Anti-gastroesophageal Reflux |
| Applicant | Allergan, Inc. |
| Date Received | 1990-06-21 |
| Decision Date | 1990-10-25 |
| PMA | P790006 |
| Supplement | S005 |
| Product Code | LEI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Allergan, Inc. 5540 Ekwill Street santa Barbara, CA 93111 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790006 | Original Filing | |
| S005 | 1990-06-21 | Normal 180 Day Track |
| S004 | 1984-05-03 | |
| S003 | 1983-06-13 | |
| S002 | 1981-04-02 | |
| S001 | 1980-01-10 |