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 PORCINE BIOPROSTHESIS |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Date Received | 1987-12-08 |
| Decision Date | 1989-09-28 |
| Notice Date | 1989-10-27 |
| PMA | P870078 |
| Supplement | S |
| Product Code | DYE |
| Docket Number | 89M-0426 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 1851 E. Deere Avenue santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870078 | Original Filing | |
| S049 | 2020-11-19 | 30-day Notice |
| S048 | ||
| S047 | 2019-09-26 | Real-time Process |
| S046 | 2019-06-20 | 30-day Notice |
| S045 | 2019-01-29 | 30-day Notice |
| S044 | ||
| S043 | 2018-10-01 | 30-day Notice |
| S042 | 2018-06-21 | 30-day Notice |
| S041 | 2018-04-12 | 30-day Notice |
| S040 | 2017-12-20 | 30-day Notice |
| S039 | ||
| S038 | 2017-09-11 | 30-day Notice |
| S037 | 2017-08-14 | 135 Review Track For 30-day Notice |
| S036 | 2017-07-10 | 30-day Notice |
| S035 | 2017-02-08 | 30-day Notice |
| S034 | 2016-10-25 | 30-day Notice |
| S033 | 2016-09-22 | 30-day Notice |
| S032 | 2016-05-06 | 30-day Notice |
| S031 | 2016-01-29 | Real-time Process |
| S030 | 2015-10-13 | 30-day Notice |
| S029 | 2014-11-07 | 30-day Notice |
| S028 | 2014-10-14 | 30-day Notice |
| S027 | 2014-08-05 | 30-day Notice |
| S026 | 2014-06-23 | 30-day Notice |
| S025 | 2014-04-23 | 30-day Notice |
| S024 | 2013-10-25 | Real-time Process |
| S023 | 2013-09-27 | 30-day Notice |
| S022 | 2013-07-01 | 30-day Notice |
| S021 | 2013-04-02 | 135 Review Track For 30-day Notice |
| S020 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S019 | 2013-04-01 | 30-day Notice |
| S018 | 2012-12-13 | 30-day Notice |
| S017 | 2012-11-19 | 30-day Notice |
| S016 | ||
| S015 | 2012-03-23 | Normal 180 Day Track |
| S014 | ||
| S013 | 2010-10-21 | 30-day Notice |
| S012 | 2010-10-20 | 30-day Notice |
| S011 | 2010-10-14 | 30-day Notice |
| S010 | 2010-06-18 | 30-day Notice |
| S009 | 2010-04-30 | 30-day Notice |
| S008 | 2010-03-31 | Normal 180 Day Track |
| S007 | 2010-01-06 | 30-day Notice |
| S006 | 2008-09-02 | Normal 180 Day Track |
| S005 | 1999-08-31 | Normal 180 Day Track |
| S004 | 1998-04-06 | Normal 180 Day Track |
| S003 | 1992-12-18 | Normal 180 Day Track |
| S002 | 1992-07-20 | Normal 180 Day Track |
| S001 | 1989-10-13 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00681490908474 | P870078 | 006 |
| 00681490908641 | P870078 | 006 |
| 00681490908597 | P870078 | 006 |
| 00613994578662 | P870078 | 006 |
| 00613994578679 | P870078 | 006 |
| 00613994578686 | P870078 | 006 |
| 00681490908559 | P870078 | 006 |
| 00681490908528 | P870078 | 006 |
| 00681490908504 | P870078 | 006 |
| 00681490908696 | P870078 | 006 |
| 00613994796042 | P870078 | 008 |
| 00613994796035 | P870078 | 008 |
| 00613994796028 | P870078 | 008 |
| 00613994796011 | P870078 | 008 |
| 00643169646506 | P870078 | 031 |
| 00643169646544 | P870078 | 031 |
| 00643169646537 | P870078 | 031 |
| 00643169646520 | P870078 | 031 |
| 00643169646483 | P870078 | 031 |
| 00643169646490 | P870078 | 031 |
| 00643169646513 | P870078 | 031 |