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 | EPIC 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 | P040021 |
| Supplement | S020 |
| 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 |
|---|
| P040021 | | Original Filing |
| S051 |
2022-11-18 |
30-day Notice |
| S050 |
2022-04-06 |
30-day Notice |
| S049 |
2022-03-16 |
30-day Notice |
| S048 |
2021-11-08 |
30-day Notice |
| S047 |
2021-06-21 |
Real-time Process |
| S046 |
2021-04-30 |
Special (immediate Track) |
| S045 |
2020-11-24 |
30-day Notice |
| S044 |
2020-09-15 |
30-day Notice |
| S043 |
2020-03-27 |
30-day Notice |
| S042 |
2019-11-13 |
30-day Notice |
| S041 |
2019-05-09 |
30-day Notice |
| S040 |
2019-02-27 |
30-day Notice |
| S039 |
2019-02-13 |
30-day Notice |
| S038 |
2019-01-24 |
30-day Notice |
| S037 |
2018-10-24 |
Real-time Process |
| S036 |
2018-05-14 |
30-day Notice |
| S035 |
2018-03-27 |
30-day Notice |
| S034 |
2018-01-11 |
30-day Notice |
| S033 |
2017-11-28 |
30-day Notice |
| S032 |
2017-09-06 |
30-day Notice |
| S031 | | |
| S030 |
2016-12-22 |
30-day Notice |
| S029 |
2016-07-01 |
30-day Notice |
| S028 |
2016-03-29 |
Normal 180 Day Track No User Fee |
| S027 |
2015-12-30 |
135 Review Track For 30-day Notice |
| S026 |
2015-01-21 |
30-day Notice |
| S025 |
2014-02-28 |
30-day Notice |
| S024 |
2013-06-10 |
135 Review Track For 30-day Notice |
| S023 |
2013-03-05 |
Real-time Process |
| S022 |
2012-04-17 |
Normal 180 Day Track No User Fee |
| S021 |
2012-03-22 |
Special (immediate Track) |
| S020 |
2011-08-17 |
Real-time Process |
| S019 |
2011-07-28 |
135 Review Track For 30-day Notice |
| S018 |
2011-06-06 |
135 Review Track For 30-day Notice |
| S017 | | |
| S016 |
2011-01-06 |
Normal 180 Day Track No User Fee |
| S015 |
2010-10-18 |
Normal 180 Day Track No User Fee |
| S014 |
2010-09-30 |
Normal 180 Day Track No User Fee |
| S013 |
2010-09-30 |
30-day Notice |
| S012 |
2010-06-23 |
135 Review Track For 30-day Notice |
| S011 |
2009-08-17 |
Normal 180 Day Track No User Fee |
| S010 |
2009-08-14 |
30-day Notice |
| S009 |
2009-05-27 |
30-day Notice |
| S008 |
2009-03-27 |
Normal 180 Day Track No User Fee |
| S007 |
2008-07-31 |
Normal 180 Day Track |
| S006 |
2008-03-12 |
Normal 180 Day Track No User Fee |
| S005 |
2006-09-20 |
Normal 180 Day Track No User Fee |
| S004 |
2006-09-29 |
Panel Track |
| S003 |
2006-08-07 |
Normal 180 Day Track |
| S002 | | |
| S001 |
2005-09-06 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices