Protege RX Carotid Stent System

FDA Premarket Approval P060001 S033

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceProtege RX Carotid Stent System
Generic NameStent, Carotid
ApplicantMEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS033 Date Received03/29/2022 Decision Date05/23/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-03-29
Decision Date2022-05-23
PMAP060001
SupplementS033
Product CodeNIM 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC VASCULAR INC
3033 Campus Drive
plymouth, MN 55441 PMA NumberP060001 Supplement NumberS033 Date Received03/29/2022 Decision Date05/23/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
increasing The Tolerance Of The Delivery System Component

Supplemental Filings

Supplement NumberDateSupplement Type
P060001Original Filing
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
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