This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| 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 | 1989-07-26 |
| Decision Date | 1989-11-14 |
| PMA | P790007 |
| Supplement | S009 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |