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 the glutaraldehyde stock solution that is obtained from dowchemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution.
| Device | HANCOCK II PORCINE BIOPROSTHESIS |
| Classification Name | Replacement Heart-valve |
| Generic Name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Date Received | 2012-03-23 |
| Decision Date | 2013-01-10 |
| PMA | P980043 |
| Supplement | S034 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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) |