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, and Zenus MRI |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS073 Date Received07/01/2022 Decision Date07/14/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-01 |
| Decision Date | 2022-07-14 |
| PMA | P140033 |
| Supplement | S073 |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Abbott Medical 15900 Valley View Court sylmar, CA 91335 PMA NumberP140033 Supplement NumberS073 Date Received07/01/2022 Decision Date07/14/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement a Second-tier Supplier's Manufacturing Site Transfer |
| 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 |