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 | LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER). |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ENDOLOGIX, INC. |
| Date Received | 1997-03-03 |
| Decision Date | 1998-04-08 |
| PMA | P970052 |
| Supplement | S001 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ENDOLOGIX, INC. 11 Studebaker irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970052 | Original Filing | |
| S002 | 1997-11-19 | Normal 180 Day Track |
| S001 | 1997-03-03 |