Reduction in frequency of bioburden testing at the penang, malaysia manufacturing site.
| Device | Assurity MRI; Endurity MRI; Tendril MRI |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2018-07-17 |
| Decision Date | 2018-08-14 |
| PMA | P140033 |
| Supplement | S036 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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