Approval for cybersecurity updates to the firmware of low voltage devices, cybersecurity updates to the clinician programmer, and updates to the programmer and merlin. Net server to detect rapid battery depletion in high voltage devices.
| Device | Assurity MRI, Endurity MRI family of Pacemakers |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2017-05-17 |
| Decision Date | 2017-08-23 |
| PMA | P140033 |
| Supplement | S008 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
Supplemental Filings
| 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 |
NIH GUDID Devices