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.
Approval for modifications to your secondary and tertiary packaging, including the addition of two new materials: a temperature indicator (to be placed in the secondary package) and a clear end seal label.
| Device | HANCOCK II PORCINE BIOPROSTHESIS |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Date Received | 2011-02-15 |
| Decision Date | 2011-04-15 |
| PMA | P980043 |
| Supplement | S030 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980043 | Original Filing | |
| S075 | 2020-11-19 | 30-day Notice |
| S074 | ||
| S073 | 2020-04-08 | 30-day Notice |
| S072 | 2019-09-26 | Real-time Process |
| S071 | 2019-06-20 | 30-day Notice |
| S070 | 2019-01-29 | 30-day Notice |
| S069 | ||
| S068 | 2018-09-24 | 30-day Notice |
| S067 | 2018-06-21 | 30-day Notice |
| S066 | 2018-04-12 | 30-day Notice |
| S065 | 2017-12-20 | 30-day Notice |
| S064 | ||
| S063 | 2017-09-11 | 30-day Notice |
| S062 | 2017-08-14 | 135 Review Track For 30-day Notice |
| S061 | 2017-07-10 | 30-day Notice |
| S060 | ||
| S059 | 2017-03-24 | 135 Review Track For 30-day Notice |
| S058 | 2017-02-22 | 30-day Notice |
| S057 | 2017-02-08 | 30-day Notice |
| S056 | 2016-11-10 | Real-time Process |
| S055 | 2016-10-25 | 30-day Notice |
| S054 | 2016-05-06 | 30-day Notice |
| S053 | 2016-05-02 | 30-day Notice |
| S052 | 2015-10-13 | 30-day Notice |
| S051 | 2014-11-07 | 30-day Notice |
| S050 | 2014-10-14 | 30-day Notice |
| S049 | 2014-08-05 | 30-day Notice |
| S048 | 2014-07-21 | Normal 180 Day Track |
| S047 | 2014-06-23 | 30-day Notice |
| S046 | 2014-06-13 | 30-day Notice |
| S045 | 2014-04-23 | 30-day Notice |
| S044 | 2013-09-17 | 30-day Notice |
| S043 | 2013-07-01 | 30-day Notice |
| S042 | 2013-04-02 | 135 Review Track For 30-day Notice |
| S041 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S040 | 2013-04-01 | 30-day Notice |
| S039 | 2013-02-13 | 30-day Notice |
| S038 | 2012-12-13 | 30-day Notice |
| S037 | 2012-11-29 | 30-day Notice |
| S036 | 2012-11-19 | 30-day Notice |
| S035 | 2012-03-14 | 30-day Notice |
| S034 | 2012-03-23 | Normal 180 Day Track |
| S033 | 2011-08-17 | 30-day Notice |
| S032 | 2011-07-28 | 30-day Notice |
| S031 | ||
| S030 | 2011-02-15 | Real-time Process |
| S029 | 2010-10-21 | 30-day Notice |
| S028 | 2010-10-20 | 30-day Notice |
| S027 | 2010-06-18 | 30-day Notice |
| S026 | 2010-04-30 | 30-day Notice |
| S025 | 2010-03-11 | 30-day Notice |
| S024 | 2010-01-06 | 30-day Notice |
| S023 | 2010-01-06 | 135 Review Track For 30-day Notice |
| S022 | 2009-10-05 | 30-day Notice |
| S021 | 2009-07-31 | Real-time Process |
| S020 | 2009-07-09 | 30-day Notice |
| S019 | ||
| S018 | 2009-01-21 | Real-time Process |
| S017 | 2008-05-20 | Real-time Process |
| S016 | 2008-02-07 | 135 Review Track For 30-day Notice |
| S015 | 2007-11-13 | Special (immediate Track) |
| S014 | 2007-10-15 | 30-day Notice |
| S013 | 2007-09-19 | 30-day Notice |
| S012 | 2007-06-19 | Real-time Process |
| S011 | ||
| S010 | 2006-08-03 | 30-day Notice |
| S009 | 2006-02-06 | Real-time Process |
| S008 | 2005-12-30 | 30-day Notice |
| S007 | 2005-12-27 | 135 Review Track For 30-day Notice |
| S006 | ||
| S005 | 2004-09-23 | Real-time Process |
| S004 | 2003-12-22 | Special (immediate Track) |
| S003 | ||
| S002 | 2002-05-01 | Normal 180 Day Track |
| S001 | 2002-04-08 | Special (immediate Track) |