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Device | ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | BOSTON SCIENTIFIC ONE SCIMED PLACE MS A350 MAPLE GROVE, MN 55311-1566 |
PMA Number | P050025 |
Date Received | 07/15/2005 |
Decision Date | 10/27/2006 |
Product Code |
NIM |
Docket Number | 06M-0459 |
Notice Date | 11/13/2006 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S002 S003 S005 S006 S007 S008 |