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 modifications to the guardian(tm) balloon coronary dilatation catheter.
| Device | GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ENDOLOGIX, INC. |
| Date Received | 1997-11-19 |
| Decision Date | 1998-05-19 |
| PMA | P970052 |
| Supplement | S002 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |