Approval for the epic valve in aortic sizes 21, 23, 25, 27 and 29 mm, and in mitral sizes 27, 29, 31 and 33 mm, and the sjm epic supra valve in aortic valve sizes 19, 21, 23, 25 and 27 mm. The device is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.
| Device | SJM EPIC VALVE AND SJM EPIC SUPRA VALVE |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2006-09-29 |
| Decision Date | 2007-11-15 |
| Notice Date | 2008-02-05 |
| PMA | P040021 |
| Supplement | S004 |
| Product Code | DYE |
| Docket Number | 08M-0084 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. 177 E.county Rd. B East st Paul, MN 55117 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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