To update laser weld inspection criteria and processing at medtronic's swiss manufacturing operations
Device | Micra AV TPS, Micra TPS |
Generic Name | Leadless Pacemaker |
Applicant | MEDTRONIC Inc. |
Date Received | 2021-03-26 |
Decision Date | 2021-04-02 |
PMA | P150033 |
Supplement | S103 |
Product Code | PNJ |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | Yes |
Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P150033 | | Original Filing |
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