MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE

Replacement Heart-valve

FDA Premarket Approval P990064

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the mosaic(r) porcine bioprosthesis, models 305 and 310 in the following sizes: model 305 (aortic) 21, 23, 25, 27 and 29 mm; model 310 (mitral) 25, 27, 29 and 31 mm. This device is indicated for the replacement of malfunctioning native or prosthetic aortic and mitral heart valves.

DeviceMEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
Classification NameReplacement Heart-valve
Generic NameReplacement Heart-valve
ApplicantMedtronic, Inc.
Date Received1999-10-08
Decision Date2000-07-14
Notice Date2000-08-03
PMAP990064
SupplementS
Product CodeDYE
Docket Number00M-1416
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P990064Original 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

NIH GUDID Devices

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