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 use of covidien medical products (shanghai) manufacturing llc located in shanghai, china as an alternate manufacturing facility for the receiving and processing of raw tissue valve components used in the manufacture of medtronic bioprosthetic valves.
| Device | Mosaic Bioprosthesis, Models 305 and 310 |
| Generic Name | Replacement Heart-valve |
| Applicant | Medtronic, Inc. |
| Date Received | 2017-03-24 |
| Decision Date | 2017-06-30 |
| PMA | P990064 |
| Supplement | S068 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990064 | Original Filing | |
| S084 | 2020-11-19 | 30-day Notice |
| S083 | ||
| S082 | 2020-04-10 | 135 Review Track For 30-day Notice |
| S081 | 2020-01-09 | 30-day Notice |
| S080 | 2019-09-26 | Real-time Process |
| S079 | 2019-06-20 | 30-day Notice |
| S078 | 2019-01-29 | 30-day Notice |
| S077 | ||
| S076 | 2018-09-24 | 30-day Notice |
| S075 | 2018-04-12 | 30-day Notice |
| S074 | 2017-12-20 | 30-day Notice |
| S073 | 2017-10-18 | 30-day Notice |
| S072 | ||
| S071 | 2017-09-11 | 30-day Notice |
| S070 | 2017-08-14 | 135 Review Track For 30-day Notice |
| S069 | 2017-07-10 | 30-day Notice |
| S068 | 2017-03-24 | 135 Review Track For 30-day Notice |
| S067 | 2017-02-22 | 30-day Notice |
| S066 | 2017-02-08 | 30-day Notice |
| S065 | 2016-11-10 | Real-time Process |
| S064 | 2016-10-25 | 30-day Notice |
| S063 | 2016-05-06 | 30-day Notice |
| S062 | 2016-05-02 | 30-day Notice |
| S061 | 2015-10-13 | 30-day Notice |
| S060 | 2014-11-07 | 30-day Notice |
| S059 | 2014-10-14 | 30-day Notice |
| S058 | 2014-08-05 | 30-day Notice |
| S057 | 2014-07-21 | Normal 180 Day Track |
| S056 | 2014-06-23 | 30-day Notice |
| S055 | 2014-06-13 | 30-day Notice |
| S054 | 2014-04-23 | 30-day Notice |
| S053 | 2014-01-09 | Special (immediate Track) |
| S052 | 2013-09-17 | 30-day Notice |
| S051 | 2013-07-01 | 30-day Notice |
| S050 | 2013-04-02 | 135 Review Track For 30-day Notice |
| S049 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S048 | 2013-04-01 | 30-day Notice |
| S047 | 2013-02-13 | 30-day Notice |
| S046 | 2012-12-13 | 30-day Notice |
| S045 | 2012-11-29 | 30-day Notice |
| S044 | 2012-11-19 | 30-day Notice |
| S043 | 2012-05-31 | 30-day Notice |
| S042 | 2012-03-14 | 30-day Notice |
| S041 | 2012-03-23 | Normal 180 Day Track |
| S040 | 2011-08-17 | 30-day Notice |
| S039 | 2011-07-28 | 30-day Notice |
| S038 | ||
| S037 | 2011-02-15 | Real-time Process |
| S036 | 2010-10-21 | 30-day Notice |
| S035 | 2010-10-20 | 30-day Notice |
| S034 | 2010-08-10 | 30-day Notice |
| S033 | 2010-04-30 | 30-day Notice |
| S032 | 2010-03-11 | 30-day Notice |
| S031 | 2010-01-06 | 30-day Notice |
| S030 | 2010-01-06 | 135 Review Track For 30-day Notice |
| S029 | 2009-10-05 | 30-day Notice |
| S028 | 2009-07-31 | Real-time Process |
| S027 | 2009-07-09 | 30-day Notice |
| S026 | 2009-01-21 | Real-time Process |
| S025 | 2008-07-11 | 30-day Notice |
| S024 | 2008-05-20 | Real-time Process |
| S023 | 2008-02-07 | 135 Review Track For 30-day Notice |
| S022 | 2007-11-13 | Special (immediate Track) |
| S021 | 2007-10-15 | 30-day Notice |
| S020 | 2007-09-19 | 30-day Notice |
| S019 | 2007-07-02 | 135 Review Track For 30-day Notice |
| S018 | 2007-06-19 | Real-time Process |
| S017 | ||
| S016 | 2006-08-03 | 30-day Notice |
| S015 | 2006-04-17 | Normal 180 Day Track No User Fee |
| S014 | 2006-02-06 | Real-time Process |
| S013 | 2005-12-30 | 30-day Notice |
| S012 | 2005-12-27 | 135 Review Track For 30-day Notice |
| S011 | ||
| S010 | 2004-09-23 | Real-time Process |
| S009 | 2003-12-22 | Special (immediate Track) |
| S008 | ||
| S007 | 2002-05-06 | Normal 180 Day Track |
| S006 | ||
| S005 | 2001-04-02 | Normal 180 Day Track |
| S004 | 2000-08-29 | Normal 180 Day Track |
| S003 | ||
| S002 | 2000-08-01 | 30-day Notice |
| S001 | 2000-07-31 | 30-day Notice |