| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
| |
| Trade Name | EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM |
|---|
| Classification Name | stent, carotid |
|---|
| Applicant | MEDTRONIC VASCULAR |
|---|
| PMA Number | P070012 |
|---|
| Date Received | 04/30/2007 |
|---|
| Decision Date | 10/23/2007 |
|---|
| Product Code | |
| Docket Number | 07M-0411 |
|---|
| Notice Date | 11/09/2007 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the exponent self-expanding carotid stent system with over-the-wire or rapid-exchange delivery system. The device is indicated for use, in conjunction with a medtronic vascular embolic protection system, for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >=50% stenosis of the common or internal carotid artery by either ultrasound or angiogram, or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by either ultrasound or angiogram; and 2) patients having a vessel with reference diameters between 4. 5 mm and 9. 5 mm at the target lesion. |
| Approval Order |
Approval Order
|
| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 |
|
|
