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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.
 
Trade NameENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
Classification Namestent, carotid
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC
PMA NumberP050025
Date Received07/15/2005
Decision Date10/27/2006
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 06M-0459
Notice Date 11/13/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the endotex nexstent. This device is indicated for treatment of 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 duplex ultrasound or angiogram or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by ultrasound or angiogram, and 2) patients must have a reference vessel diameter within the range of 4mm and 9mm at the target lesion and a stenosis less than 30mm in length.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S005 S006 S007 S008 
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