Addition of an alternate contract sterilizer vendor for the sterilization of the jar set assemblies.
| Device | SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2016-12-22 |
| Decision Date | 2017-02-03 |
| PMA | P040021 |
| Supplement | S030 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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