Addition of an alternate analytical testing laboratory for monolithic controlled release devices and the addition of an alternate vendor to supply polyhexamethylene oxide which is used in the manufacture of optim.
| Device | Tendril MRI |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2017-02-08 |
| Decision Date | 2017-02-21 |
| PMA | P140033 |
| Supplement | S001 |
| Product Code | DXY |
| 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