This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the fact(tm), arc(tm), lynx(tm) and guardian(tm) balloon coronary dilatation catheters. These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purposed of improving myocardial perfusion. The application includes authorization from endosoncis corp. , rancho cordova, ca, to incorporate information contained in its approved premarket approval application and related supplements for hte cathscanner(r) oracle(r) micro ptca catheter.
| Device | FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ENDOLOGIX, INC. |
| Date Received | 1997-11-04 |
| Decision Date | 1998-02-20 |
| Notice Date | 1998-03-20 |
| PMA | P970052 |
| Supplement | S |
| Product Code | LOX |
| Docket Number | 98M-0162 |
| 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 |