PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS

Stent, Carotid

FDA Premarket Approval P060001

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.

Pre-market Approval Supplement Details

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.

DevicePROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
Classification NameStent, Carotid
Generic NameStent, Carotid
ApplicantMEDTRONIC VASCULAR INC
Date Received2006-01-09
Decision Date2007-01-24
Notice Date2007-02-09
PMAP060001
SupplementS
Product CodeNIM
Docket Number07M-0049
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P060001Original Filing
S035 2022-11-15 30-day Notice
S034 2022-05-25 30-day Notice
S033 2022-03-29 Real-time Process
S032 2021-04-08 30-day Notice
S031 2020-12-10 30-day Notice
S030 2020-07-21 30-day Notice
S029 2020-05-06 Real-time Process
S028 2019-05-24 30-day Notice
S027 2019-05-03 30-day Notice
S026 2017-11-03 30-day Notice
S025
S024 2015-11-23 30-day Notice
S023 2015-03-16 30-day Notice
S022 2014-07-21 30-day Notice
S021 2014-06-05 30-day Notice
S020 2014-05-02 Panel Track
S019 2013-01-30 30-day Notice
S018 2012-10-09 30-day Notice
S017 2012-08-21 Normal 180 Day Track No User Fee
S016 2011-12-19 30-day Notice
S015
S014 2011-05-31 30-day Notice
S013 2011-04-29 30-day Notice
S012 2011-04-27 30-day Notice
S011 2011-02-16 Normal 180 Day Track No User Fee
S010 2010-09-07 30-day Notice
S009 2010-05-20 30-day Notice
S008 2010-03-29 Special (immediate Track)
S007 2008-05-27 30-day Notice
S006 2008-05-16 Normal 180 Day Track No User Fee
S005 2008-03-07 30-day Notice
S004 2007-12-31 30-day Notice
S003 2007-02-16 Normal 180 Day Track No User Fee
S002 2007-01-31 135 Review Track For 30-day Notice
S001 2007-01-29 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00821684038499 P060001 019
00821684038628 P060001 019
00821684038635 P060001 019
00821684038642 P060001 019
00821684038659 P060001 019
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00821684038673 P060001 019
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00821684038505 P060001 019
00821684038512 P060001 019
00821684038529 P060001 019
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00821684038543 P060001 019
00821684038550 P060001 019
00821684038567 P060001 019
00821684038574 P060001 019
00821684038581 P060001 019
00821684038598 P060001 019
00643169729131 P060001 020
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00643169729117 P060001 020
00643169729124 P060001 020
00643169729148 P060001 020
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00643169729162 P060001 020
00643169729179 P060001 020
00643169729186 P060001 020
00643169729063 P060001 020
00643169729056 P060001 020
00643169728936 P060001 020
00643169728943 P060001 020
00643169728950 P060001 020
00643169728967 P060001 020
00643169728974 P060001 020
00643169728998 P060001 020
00643169729001 P060001 020
00643169729018 P060001 020
00643169729025 P060001 020
00643169729032 P060001 020
00643169729049 P060001 020
00643169729193 P060001 020

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