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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestent, carotid
Generic Namestent, carotid
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403-1774
PMA NumberP070012
Date Received04/30/2007
Decision Date10/23/2007
Withdrawal Date 09/20/2013
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 07M-0411
Notice Date 11/09/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001