Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis

FDA Premarket Approval P990064 S082

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.

Pre-market Approval Supplement Details

Approval for removal of the leaflet touching bias inspection

DeviceMosaic Bioprosthesis and Mosaic Ultra Bioprosthesis
Generic NameReplacement Heart-valve
ApplicantMedtronic, Inc.
Date Received2020-04-10
Decision Date2020-11-03
PMAP990064
SupplementS082
Product CodeDYE 
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P990064Original Filing
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

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