Micra AV TPS, Micra TPS

FDA Premarket Approval P150033 S138

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

DeviceMicra AV TPS, Micra TPS
Generic NameLeadless Pacemaker
ApplicantMEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS138 Date Received04/27/2022 Decision Date05/03/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-27
Decision Date2022-05-03
PMAP150033
SupplementS138
Product CodePNJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMEDTRONIC Inc.
8200 Coral Sea Street Ne
ms Mv S11
mounds View, MN 55112 PMA NumberP150033 Supplement NumberS138 Date Received04/27/2022 Decision Date05/03/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
to Implement The Replacement Of Trichloroethylene Vapor Solvent Degreaser With SolVantage Vapor Solvent Degreaser

Supplemental Filings

Supplement NumberDateSupplement Type
P150033Original Filing
S140 2022-05-11 30-day Notice
S139
S138 2022-04-27 30-day Notice
S137 2022-04-22 30-day Notice
S136 2022-04-14 30-day Notice
S135 2022-02-24 30-day Notice
S134 2022-01-28 30-day Notice
S133 2022-01-14 30-day Notice
S132 2022-01-13 30-day Notice
S131 2022-01-13 30-day Notice
S130 2022-01-10 30-day Notice
S129 2021-11-30 30-day Notice
S128 2021-11-19 30-day Notice
S127
S126 2021-11-10 30-day Notice
S125 2021-10-12 30-day Notice
S124 2021-10-05 30-day Notice
S123 2021-10-04 30-day Notice
S122 2021-10-01 30-day Notice
S121
S120 2021-09-22 30-day Notice
S119 2021-09-22 30-day Notice
S118 2021-09-08 30-day Notice
S117
S116 2021-07-09 30-day Notice
S115 2021-07-09 30-day Notice
S114 2021-07-08 30-day Notice
S113 2021-07-01 30-day Notice
S112 2021-06-23 30-day Notice
S111 2021-06-21 30-day Notice
S110 2021-06-11 30-day Notice
S109 2021-05-27 30-day Notice
S108
S107
S106 2021-04-27 30-day Notice
S105 2021-04-23 Special (immediate Track)
S104
S103 2021-03-26 30-day Notice
S102
S101
S100
S099 2021-03-16 30-day Notice
S098
S097 2021-03-09 30-day Notice
S096
S095
S094 2021-02-09 30-day Notice
S093
S092 2021-01-21 30-day Notice
S091 2020-11-24 30-day Notice
S090
S089 2020-11-19 30-day Notice
S088
S087 2020-10-23 30-day Notice
S086 2020-09-23 30-day Notice
S085
S084 2020-07-30 30-day Notice
S083 2020-07-27 30-day Notice
S082 2020-07-14 30-day Notice
S081 2020-07-13 30-day Notice
S080 2020-07-10 30-day Notice
S079 2020-07-09 30-day Notice
S078 2020-07-02 Normal 180 Day Track No User Fee
S077
S076 2020-06-26 30-day Notice
S075 2020-05-29 Real-time Process
S074 2020-05-15 30-day Notice
S073 2020-05-11 30-day Notice
S072 2020-04-28 30-day Notice
S071 2020-04-09 30-day Notice
S070
S069 2020-03-30 30-day Notice
S068 2020-03-12 30-day Notice
S067
S066 2020-02-20 30-day Notice
S065 2019-12-23 Real-time Process
S064 2019-12-11 30-day Notice
S063 2019-11-18 30-day Notice
S062
S061
S060 2019-10-24 30-day Notice
S059 2019-09-27 Real-time Process
S058 2019-09-17 30-day Notice
S057 2019-09-16 30-day Notice
S056 2019-09-16 30-day Notice
S055 2019-06-10 30-day Notice
S054 2019-04-11 30-day Notice
S053 2019-03-28 30-day Notice
S052
S051
S050
S049 2019-02-26 30-day Notice
S048 2019-01-23 30-day Notice
S047 2018-11-27 30-day Notice
S046 2018-10-23 30-day Notice
S045 2018-10-18 30-day Notice
S044 2018-10-15 30-day Notice
S043 2018-10-09 30-day Notice
S042 2018-09-26 30-day Notice
S041 2018-08-22 Real-time Process
S040 2018-08-08 30-day Notice
S039 2018-06-28 Normal 180 Day Track No User Fee
S038 2018-07-06 Real-time Process
S037
S036 2018-04-17 Real-time Process
S035 2018-04-12 30-day Notice
S034 2018-04-09 30-day Notice
S033 2018-03-12 30-day Notice
S032 2018-02-01 Real-time Process
S031 2018-01-30 30-day Notice
S030 2018-01-17 30-day Notice
S029 2017-12-22 30-day Notice
S028 2017-11-20 30-day Notice
S027 2017-09-05 Real-time Process
S026 2017-07-28 30-day Notice
S025 2017-06-23 30-day Notice
S024 2017-06-09 30-day Notice
S023 2017-05-12 30-day Notice
S022 2017-03-31 30-day Notice
S021 2017-03-29 30-day Notice
S020 2017-03-13 Real-time Process
S019 2017-03-03 30-day Notice
S018 2017-02-21 Real-time Process
S017 2017-02-17 30-day Notice
S016 2017-02-02 30-day Notice
S015 2017-02-01 Normal 180 Day Track
S014 2017-01-13 30-day Notice
S013 2016-11-23 Real-time Process
S012 2016-11-16 Normal 180 Day Track
S011 2016-11-14 30-day Notice
S010 2016-10-07 30-day Notice
S009 2016-09-30 Real-time Process
S008 2016-09-29 30-day Notice
S007 2016-09-26 30-day Notice
S006 2016-07-22 30-day Notice
S005 2016-07-22 30-day Notice
S004 2016-07-01 30-day Notice
S003 2016-05-23 Real-time Process
S002 2016-05-06 Real-time Process
S001 2016-04-29 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169529748 P150033 000
00643169711761 P150033 015
00763000078621 P150033 061

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