This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | HANCOCK MODIFIED ORIFICE BIOPROSTHESIS |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | MEDTRONIC HEART VALVES |
| Date Received | 1979-02-21 |
| Decision Date | 1979-11-15 |
| Notice Date | 1980-08-08 |
| PMA | P790007 |
| Supplement | S |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC HEART VALVES 1851 East Deere Ave. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790007 | Original Filing | |
| S064 | 2020-11-19 | 30-day Notice |
| S063 | ||
| S062 | 2019-09-26 | Real-time Process |
| S061 | 2019-06-20 | 30-day Notice |
| S060 | 2019-01-29 | 30-day Notice |
| S059 | ||
| S058 | 2018-10-01 | 30-day Notice |
| S057 | 2018-06-21 | 30-day Notice |
| S056 | 2018-04-12 | 30-day Notice |
| S055 | 2017-12-20 | 30-day Notice |
| S054 | ||
| S053 | 2017-09-11 | 30-day Notice |
| S052 | 2017-08-14 | 135 Review Track For 30-day Notice |
| S051 | 2017-07-10 | 30-day Notice |
| S050 | 2017-02-08 | 30-day Notice |
| S049 | 2016-10-25 | 30-day Notice |
| S048 | 2016-05-06 | 30-day Notice |
| S047 | 2016-01-29 | Real-time Process |
| S046 | 2015-10-13 | 30-day Notice |
| S045 | 2014-11-07 | 30-day Notice |
| S044 | 2014-10-14 | 30-day Notice |
| S043 | 2014-08-05 | 30-day Notice |
| S042 | 2014-06-23 | 30-day Notice |
| S041 | 2014-04-23 | 30-day Notice |
| S040 | 2013-10-25 | Real-time Process |
| S039 | 2013-07-01 | 30-day Notice |
| S038 | 2013-04-02 | 135 Review Track For 30-day Notice |
| S037 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S036 | 2013-04-01 | 30-day Notice |
| S035 | 2013-02-13 | 30-day Notice |
| S034 | 2012-12-13 | 30-day Notice |
| S033 | 2012-11-19 | 30-day Notice |
| S032 | 2012-03-23 | Normal 180 Day Track |
| S031 | 2011-08-17 | 30-day Notice |
| S030 | 2011-07-28 | 30-day Notice |
| S029 | ||
| S028 | 2010-10-21 | 30-day Notice |
| S027 | 2010-10-20 | 30-day Notice |
| S026 | 2010-06-18 | 30-day Notice |
| S025 | 2010-04-30 | 30-day Notice |
| S024 | 2010-01-06 | 135 Review Track For 30-day Notice |
| S023 | 2009-10-05 | 30-day Notice |
| S022 | 2009-07-09 | 30-day Notice |
| S021 | 2007-10-15 | 30-day Notice |
| S020 | 2007-09-19 | 30-day Notice |
| S019 | ||
| S018 | 2007-04-13 | 30-day Notice |
| S017 | 2005-12-27 | 135 Review Track For 30-day Notice |
| S016 | 1999-08-31 | Normal 180 Day Track |
| S015 | 1998-05-12 | Normal 180 Day Track |
| S014 | 1998-04-06 | Normal 180 Day Track |
| S013 | 1996-05-13 | Normal 180 Day Track |
| S012 | 1993-04-12 | Normal 180 Day Track |
| S011 | 1992-12-18 | Normal 180 Day Track |
| S010 | 1992-07-20 | Normal 180 Day Track |
| S009 | 1989-07-26 | Normal 180 Day Track |
| S008 | ||
| S007 | 1985-02-08 | |
| S006 | ||
| S005 | 1981-05-04 | |
| S004 | 1980-10-06 | |
| S003 | 1979-12-27 | |
| S002 | 1979-12-27 | |
| S001 | 1979-12-27 |
| Device ID | PMA | Supp |
|---|---|---|
| 00681490908788 | P790007 | 011 |
| 00681490908726 | P790007 | 011 |
| 00681490908740 | P790007 | 011 |
| 00681490908764 | P790007 | 011 |
| 00681490908795 | P790007 | 011 |
| 00681490908818 | P790007 | 011 |
| 00681490908832 | P790007 | 011 |
| 00643169646612 | P790007 | 047 |
| 00643169646551 | P790007 | 047 |
| 00643169646568 | P790007 | 047 |
| 00643169646575 | P790007 | 047 |
| 00643169646582 | P790007 | 047 |
| 00643169646599 | P790007 | 047 |
| 00643169646605 | P790007 | 047 |
| 00763000926472 | P790007 | 066 |
| 00763000926489 | P790007 | 066 |
| 00763000926496 | P790007 | 066 |
| 00763000926502 | P790007 | 066 |
| 00763000926519 | P790007 | 066 |
| 00763000926526 | P790007 | 066 |
| 00763000926465 | P790007 | 066 |