| 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. |
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| Device | EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM |
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| Generic Name | STENT, CAROTID |
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| Applicant | Medtronic Vascular
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774 |
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| PMA Number | P070012 |
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| Date Received | 04/30/2007 |
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| Decision Date | 10/23/2007 |
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|
Withdrawal Date
|
09/20/2013 |
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| Product Code |
NIM |
| Docket Number | 07M-0411 |
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| Notice Date | 11/09/2007 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 |
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