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 BIOPROSTHESIS MODELS 242,342,343C,342R |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Date Received | 1992-12-18 |
| Decision Date | 1993-07-02 |
| PMA | P870078 |
| Supplement | S003 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |