Medtronic Evolut PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery Catheter System, Medtronic Evolut FX Deliv

FDA Premarket Approval P130021 S125

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

DeviceMedtronic Evolut PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery Catheter System, Medtronic Evolut FX Deliv
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantMedtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS125 Date Received10/28/2022 Decision Date11/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-28
Decision Date2022-11-01
PMAP130021
SupplementS125
Product CodeNPT 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic, Inc.
710 Medtronic Parkway
minneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS125 Date Received10/28/2022 Decision Date11/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of Process Monitoring Software In The Manufacturing Of The EnVeo PRO, Evolut PRO+, And Evolut FX Delivery Catheter Subassemblies

Supplemental Filings

Supplement NumberDateSupplement Type
P130021Original Filing
S126 2022-10-31 30-day Notice
S125 2022-10-28 30-day Notice
S124
S123 2022-10-25 30-day Notice
S122 2022-09-12 30-day Notice
S121 2022-09-06 30-day Notice
S120
S119 2022-07-20 30-day Notice
S118 2022-06-24 30-day Notice
S117 2022-05-31 30-day Notice
S116 2022-05-16 30-day Notice
S115
S114 2022-03-29 30-day Notice
S113
S112 2022-03-17 30-day Notice
S111 2022-03-15 Special (immediate Track)
S110 2022-02-28 30-day Notice
S109
S108 2022-01-26 30-day Notice
S107 2021-12-02 30-day Notice
S106 2021-11-22 30-day Notice
S105 2021-10-12 30-day Notice
S104 2021-09-22 Special (immediate Track)
S103 2021-09-13 30-day Notice
S102 2021-07-22 Normal 180 Day Track No User Fee
S101 2021-07-09 30-day Notice
S100 2021-07-08 30-day Notice
S099
S098 2021-06-02 30-day Notice
S097
S096 2021-05-18 30-day Notice
S095
S094
S093 2021-04-27 30-day Notice
S092
S091 2021-04-20 30-day Notice
S090
S089 2021-03-23 30-day Notice
S088
S087 2021-03-04 30-day Notice
S086 2021-02-25 30-day Notice
S085 2021-02-12 Real-time Process
S084 2021-01-05 30-day Notice
S083 2020-11-12 Special (immediate Track)
S082
S081 2020-10-26 30-day Notice
S080 2020-07-10 Normal 180 Day Track No User Fee
S079 2020-07-08 30-day Notice
S078 2020-06-23 30-day Notice
S077 2020-05-22 30-day Notice
S076
S075 2020-04-30 30-day Notice
S074 2020-04-28 30-day Notice
S073 2020-03-11 Normal 180 Day Track No User Fee
S072 2020-03-04 Real-time Process
S071 2020-02-27 30-day Notice
S070 2019-12-13 30-day Notice
S069 2019-12-09 30-day Notice
S068 2019-11-01 30-day Notice
S067 2019-10-18 30-day Notice
S066 2019-10-01 30-day Notice
S065 2019-10-01 30-day Notice
S064
S063 2019-09-09 30-day Notice
S062 2019-08-22 30-day Notice
S061 2019-08-15 30-day Notice
S060 2019-06-04 30-day Notice
S059
S058 2019-03-15 Panel Track
S057 2018-11-21 30-day Notice
S056
S055 2018-10-29 30-day Notice
S054 2018-09-27 30-day Notice
S053 2018-09-24 30-day Notice
S052 2018-08-10 30-day Notice
S051 2018-06-29 Normal 180 Day Track
S050 2018-06-25 30-day Notice
S049 2017-12-21 30-day Notice
S048 2017-12-07 30-day Notice
S047 2017-11-30 30-day Notice
S046 2017-11-14 30-day Notice
S045 2017-10-18 30-day Notice
S044
S043 2017-09-29 Normal 180 Day Track
S042 2017-09-11 30-day Notice
S041 2017-08-04 Normal 180 Day Track No User Fee
S040 2017-08-04 30-day Notice
S039 2017-07-07 30-day Notice
S038 2017-06-01 30-day Notice
S037 2017-04-10 30-day Notice
S036 2017-03-15 30-day Notice
S035 2017-03-09 30-day Notice
S034 2017-03-09 Normal 180 Day Track No User Fee
S033 2017-03-06 Panel Track
S032 2017-03-06 30-day Notice
S031 2017-02-21 135 Review Track For 30-day Notice
S030 2017-02-08 30-day Notice
S029 2017-02-06 Normal 180 Day Track
S028 2017-01-13 Normal 180 Day Track
S027 2016-11-30 30-day Notice
S026 2016-11-29 Normal 180 Day Track No User Fee
S025 2016-10-13 Normal 180 Day Track
S024 2016-08-11 Special (immediate Track)
S023 2016-07-13 30-day Notice
S022 2016-06-21 Real-time Process
S021 2016-06-16 30-day Notice
S020 2016-03-08 Real-time Process
S019 2016-02-12 30-day Notice
S018 2015-09-21 135 Review Track For 30-day Notice
S017 2015-07-28 30-day Notice
S016 2015-07-08 Normal 180 Day Track
S015 2015-07-06 30-day Notice
S014 2015-04-23 Normal 180 Day Track
S013 2015-03-25 Normal 180 Day Track
S012 2015-03-20 135 Review Track For 30-day Notice
S011 2015-03-12 30-day Notice
S010 2014-12-09 Panel Track
S009 2014-11-19 30-day Notice
S008 2014-10-06 Real-time Process
S007 2014-09-10 30-day Notice
S006 2014-08-08 30-day Notice
S005 2014-06-26 Real-time Process
S004 2014-04-10 Normal 180 Day Track
S003 2014-03-27 Special (immediate Track)
S002 2014-02-27 Panel Track
S001

NIH GUDID Devices

Device IDPMASupp
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00763000370688 P130021 094

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