| Note: 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. |
| |
| Device | FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER |
|---|
| Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
|---|
| Regulation Number | 870.5100 |
|---|
| Applicant | ABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591 |
|---|
| PMA Number | P020037 |
|---|
| Date Received | 09/10/2002 |
|---|
| Decision Date | 06/11/2003 |
|---|
|
Reclassified Date
|
10/08/2010 |
|---|
| Product Code |
LOX |
| Docket Number | 03M-0320 |
|---|
| Notice Date | 06/30/2003 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
APPROVAL FOR THE FX MINIRAIL TX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY, INCLUDING IN-STENT RESTENOSIS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 |
|
|
