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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/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.
 
DevicePROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
Generic NameSTENT, CAROTID
ApplicantMEDTRONIC VASCULAR INC
3033 Campus Drive
Plymouth, MN 55441
PMA NumberP060001
Date Received01/09/2006
Decision Date01/24/2007
Product Code NIM 
Docket Number 07M-0049
Notice Date 02/09/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USED IN CONJUNCTION WITH EV3 EMBOLIC PROTECTION DEVICES, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID REVASCULARIZATION AND MEET THE FOLLOWING CRITERIA:1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY) OF THE COMMON OR INTERNAL CAROTID ARTERY, AND2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.5 MM AND 9.5 MM AT THE TARGET LESION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S030 S032 S033 S034 S035 S040 S038 S036 S037  S022 S011 
S012 S013 S014 S020 S021 S009 S019 S023 S017 S018 S024 S016 
S004 S010 S005 S008 S001 S002 S003 S006 S007 S026 S027 S028 
S029 S031 
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