Approval to update the instructions for use (ifu), st. Jude medical (sjm) internet, and any other applicable device labeling to include the new magnetic resonance imaging (mri) testing information to enhance the safe use of the device when undergoing mri.
| Device | TRIFECA HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2011-08-17 |
| Decision Date | 2012-11-01 |
| PMA | P100029 |
| Supplement | S008 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. 177 E.county Rd. B East st Paul, MN 55117 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100029 | | Original Filing |
| S049 |
2022-11-18 |
30-day Notice |
| S048 |
2022-10-20 |
30-day Notice |
| S047 |
2022-10-20 |
30-day Notice |
| S046 |
2022-03-16 |
30-day Notice |
| S045 |
2021-11-08 |
30-day Notice |
| S044 | | |
| S043 |
2020-09-15 |
30-day Notice |
| S042 |
2019-11-13 |
30-day Notice |
| S041 | | |
| S040 |
2019-05-09 |
30-day Notice |
| S039 |
2019-02-27 |
30-day Notice |
| S038 |
2019-02-13 |
30-day Notice |
| S037 |
2018-10-23 |
30-day Notice |
| S036 |
2018-09-12 |
30-day Notice |
| S035 |
2018-08-13 |
Special (immediate Track) |
| S034 |
2018-05-14 |
30-day Notice |
| S033 |
2018-03-27 |
30-day Notice |
| S032 |
2018-03-22 |
30-day Notice |
| S031 |
2018-02-15 |
30-day Notice |
| S030 |
2018-02-01 |
30-day Notice |
| S029 |
2018-01-11 |
30-day Notice |
| S028 |
2017-11-28 |
30-day Notice |
| S027 |
2017-10-27 |
30-day Notice |
| S026 | | |
| S025 |
2017-03-07 |
30-day Notice |
| S024 |
2016-12-22 |
30-day Notice |
| S023 |
2016-12-09 |
30-day Notice |
| S022 |
2016-07-01 |
30-day Notice |
| S021 |
2015-10-02 |
Normal 180 Day Track |
| S020 |
2015-08-28 |
30-day Notice |
| S019 |
2015-01-21 |
30-day Notice |
| S018 |
2014-11-13 |
30-day Notice |
| S017 |
2014-09-05 |
30-day Notice |
| S016 |
2013-06-10 |
135 Review Track For 30-day Notice |
| S015 |
2013-05-28 |
135 Review Track For 30-day Notice |
| S014 |
2012-07-19 |
Special (immediate Track) |
| S013 |
2012-04-05 |
Real-time Process |
| S012 |
2012-03-27 |
30-day Notice |
| S011 |
2012-03-22 |
Special (immediate Track) |
| S010 |
2012-01-23 |
30-day Notice |
| S009 |
2011-09-27 |
30-day Notice |
| S008 |
2011-08-17 |
Real-time Process |
| S007 |
2011-08-08 |
30-day Notice |
| S006 |
2011-06-09 |
30-day Notice |
| S005 |
2011-06-06 |
30-day Notice |
| S004 |
2011-06-06 |
135 Review Track For 30-day Notice |
| S003 |
2011-05-20 |
Normal 180 Day Track No User Fee |
| S002 |
2011-04-27 |
135 Review Track For 30-day Notice |
| S001 |
2011-04-22 |
30-day Notice |
NIH GUDID Devices