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Device | ENROUTE TRANSCAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | SILK ROAD MEDICAL, INC 1213 Innsbruck Drive Sunnyvale, CA 94089 |
PMA Number | P140026 |
Date Received | 11/17/2014 |
Decision Date | 05/18/2015 |
Product Code |
NIM |
Docket Number | 15M-1956 |
Notice Date | 06/02/2015 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01685567
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ENROUTE TRANSCAROTID STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) FOR THE TREATMENT OF PATIENTS AT HIGH RISKFOR 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 ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; 2) PATIENTS MUST HAVE A VESSEL DIAMETER OF 4-9MM AT THE TARGET LESION; AND 3) CAROTID BIFURCATION IS LOCATED AT MINIMUM 5 CM ABOVE THE CLAVICLE TO ALLOW FOR PLACEMENT OF THE ENROUTE TRANSCAROTID NPS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 S026 S027 S028 S029 |