MEDTRONIC COREVALVE SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Premarket Approval P130021

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 medtronic corevalve™ system. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area? 0. 8 cm2, a mean aortic valve gradient of > 40 mmhg, or a peak aortic-jet velocity of > 4. 0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity? 50% at 30 days).

DeviceMEDTRONIC COREVALVE SYSTEM
Classification NameAortic Valve, Prosthesis, Percutaneously Delivered
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantMEDTRONIC COREVALVE LLC
Date Received2013-07-22
Decision Date2014-01-17
Notice Date2014-02-04
PMAP130021
SupplementS
Product CodeNPT
Docket Number14M-0166
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC COREVALVE LLC 3576 Unocal Place santa Rosa, CA 95403
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P130021Original Filing
S131 2023-01-27 30-day Notice
S130
S129 2022-11-30 30-day Notice
S128 2022-11-29 30-day Notice
S127 2022-11-18 30-day Notice
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
00643169434301 P130021 000
00643169448551 P130021 000
00643169448544 P130021 000
00643169448537 P130021 000
00643169448520 P130021 000
00643169448513 P130021 000
00643169448506 P130021 000
00643169448490 P130021 000
00643169448483 P130021 000
00643169448186 P130021 000
00643169448179 P130021 000
00643169448162 P130021 000
00643169432376 P130021 000
00643169430297 P130021 000
00643169430273 P130021 000
00643169432369 P130021 000
00643169430310 P130021 000
00643169430266 P130021 000
00643169430280 P130021 000
00643169430303 P130021 000
00643169430259 P130021 000
00643169430242 P130021 000
00643169565630 P130021 013
00643169565623 P130021 013
00643169633353 P130021 014
00643169633360 P130021 014
00643169633377 P130021 014
00643169637993 P130021 014
00643169638006 P130021 014
00643169637986 P130021 014
00643169792340 P130021 025
00643169640337 P130021 025
00643169640344 P130021 025
00643169800915 P130021 028
00643169800939 P130021 028
00643169934122 P130021 029
00643169956193 P130021 029
00643169934115 P130021 029
00643169954434 P130021 029
00643169954441 P130021 029
00643169954458 P130021 029
00763000017811 P130021 043
00763000017682 P130021 043
00763000017675 P130021 043
00763000017668 P130021 043
00763000017651 P130021 043
00763000017828 P130021 043
00763000017835 P130021 043
00643169987210 P130021 043
00643169987173 P130021 043
00643169987180 P130021 043
00643169987197 P130021 043
00643169987203 P130021 043
00763000207854 P130021 059
00763000207861 P130021 059
00763000207892 P130021 059
00763000207908 P130021 059
00763000211103 P130021 059
00763000211110 P130021 059
00763000211127 P130021 059
00763000211158 P130021 059
00763000370688 P130021 094
00763000370695 P130021 094
00763000370701 P130021 094
00763000370718 P130021 094
00763000365677 P130021 094
00763000365684 P130021 094
00763000365691 P130021 094
00763000365707 P130021 094
00763000942717 P130021 155
00763000942724 P130021 155
00763000942731 P130021 155
00763000716127 P130021 155
00763000716134 P130021 155
00763000716141 P130021 155
00763000716158 P130021 155
00763000942700 P130021 155

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.