| 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 | X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM |
|---|
| Generic Name | Device, hemostasis, vascular |
|---|
| Applicant | St. Jude Medical, Inc.
6500 WEDGWOOD RD.
MAPLE GROVE, MN 55311 |
|---|
| PMA Number | P020035 |
|---|
| Date Received | 09/03/2002 |
|---|
| Decision Date | 09/30/2003 |
|---|
|
Withdrawal Date
|
11/04/2010 |
|---|
| Product Code |
MGB |
| Docket Number | 09M-0406 |
|---|
| Notice Date | 09/25/2009 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
APPROVAL FOR THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FRENCH IN SIZE. THE DEVICE IS INTENDED TO REDUCE THE TIME TO HEMOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CARDIAC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE PATIENTS RECEIVING GLYCOPROTEIN IIB/IIIA INHIBITORS. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 |
|
|
