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.
Device | Assurity MRI, Endurity MRI |
Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
Applicant | Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS076 Date Received09/08/2022 Decision Date12/07/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
Date Received | 2022-09-08 |
Decision Date | 2022-12-07 |
PMA | P140033 |
Supplement | S076 |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | Yes |
Applicant Address | Abbott Medical 15900 Valley View Court sylmar, CA 91335 PMA NumberP140033 Supplement NumberS076 Date Received09/08/2022 Decision Date12/07/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes |
Supplement Number | Date | Supplement Type |
---|---|---|
P140033 | Original Filing | |
S076 | 2022-09-08 | Real-time Process |
S075 | 2022-07-27 | Real-time Process |
S074 | 2022-07-14 | 30-day Notice |
S073 | 2022-07-01 | 30-day Notice |
S072 | 2022-03-07 | Real-time Process |
S071 | 2021-10-18 | Real-time Process |
S070 | 2021-07-08 | Normal 180 Day Track |
S069 | 2021-06-28 | 30-day Notice |
S068 | ||
S067 | 2021-04-02 | Real-time Process |
S066 | 2021-03-12 | 30-day Notice |
S065 | ||
S064 | 2020-11-25 | 30-day Notice |
S063 | 2020-10-21 | 30-day Notice |
S062 | ||
S061 | 2020-09-30 | 30-day Notice |
S060 | ||
S059 | 2020-05-22 | 30-day Notice |
S058 | 2020-04-24 | 30-day Notice |
S057 | 2020-04-23 | Normal 180 Day Track No User Fee |
S056 | 2020-02-27 | 30-day Notice |
S055 | 2020-02-13 | 30-day Notice |
S054 | ||
S053 | 2019-12-10 | 30-day Notice |
S052 | 2019-12-09 | 30-day Notice |
S051 | 2019-11-25 | 30-day Notice |
S050 | ||
S049 | ||
S048 | ||
S047 | 2019-09-26 | 30-day Notice |
S046 | 2019-07-31 | 30-day Notice |
S045 | 2019-05-01 | 30-day Notice |
S044 | 2018-11-30 | 30-day Notice |
S043 | 2018-11-23 | 30-day Notice |
S042 | 2018-11-20 | 30-day Notice |
S041 | 2018-10-29 | Real-time Process |
S040 | 2018-10-02 | 30-day Notice |
S039 | 2018-10-01 | 30-day Notice |
S038 | 2018-09-28 | 30-day Notice |
S037 | 2018-09-04 | 30-day Notice |
S036 | 2018-07-17 | 30-day Notice |
S035 | 2018-07-02 | 30-day Notice |
S034 | 2018-06-28 | Normal 180 Day Track |
S033 | 2018-06-20 | Normal 180 Day Track |
S032 | 2018-05-21 | 30-day Notice |
S031 | ||
S030 | 2018-05-01 | 30-day Notice |
S029 | 2018-04-10 | 30-day Notice |
S028 | 2018-04-05 | 30-day Notice |
S027 | 2018-02-27 | 30-day Notice |
S026 | 2018-02-07 | 30-day Notice |
S025 | 2018-01-31 | 30-day Notice |
S024 | 2018-01-29 | 30-day Notice |
S023 | 2018-01-22 | Real-time Process |
S022 | 2018-01-18 | Normal 180 Day Track |
S021 | ||
S020 | 2017-11-29 | 30-day Notice |
S019 | 2017-11-08 | Real-time Process |
S018 | 2017-11-07 | Normal 180 Day Track |
S017 | 2017-10-30 | Real-time Process |
S016 | 2017-10-10 | 30-day Notice |
S015 | 2017-09-21 | 30-day Notice |
S014 | 2017-09-18 | 135 Review Track For 30-day Notice |
S013 | 2017-08-16 | 30-day Notice |
S012 | 2017-08-01 | Real-time Process |
S011 | 2017-07-31 | 30-day Notice |
S010 | 2017-07-03 | Normal 180 Day Track |
S009 | 2017-06-30 | 30-day Notice |
S008 | 2017-05-17 | Normal 180 Day Track |
S007 | 2017-04-06 | 30-day Notice |
S006 | 2017-04-03 | Normal 180 Day Track |
S005 | 2017-03-06 | 30-day Notice |
S004 | 2017-02-28 | 30-day Notice |
S003 | 2017-02-24 | 30-day Notice |
S002 | 2017-02-17 | 135 Review Track For 30-day Notice |
S001 | 2017-02-08 | 30-day Notice |
Device ID | PMA | Supp |
---|---|---|
05414734509602 | P140033 | 000 |
05414734509596 | P140033 | 000 |
05414734509589 | P140033 | 000 |
05414734509572 | P140033 | 000 |
05414734504683 | P140033 | 000 |
05414734504638 | P140033 | 000 |
05414734504621 | P140033 | 000 |
05414734503648 | P140033 | 000 |
05414734510059 | P140033 | 012 |