OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT

FDA Premarket Approval P990046 S028

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 a manufacturing site located in minneapolis, minnesota.

DeviceOPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT
Generic NameHeart-valve, Mechanical
ApplicantMEDTRONIC ATS MEDICAL, INC.
Date Received2012-03-23
Decision Date2013-06-28
PMAP990046
SupplementS028
Product CodeLWQ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Lane, Suite 175 plymouth, MN 55447

Supplemental Filings

Supplement NumberDateSupplement Type
P990046Original Filing
S057 2020-02-24 30-day Notice
S056 2020-02-20 30-day Notice
S055
S054 2018-06-22 30-day Notice
S053
S052 2017-10-23 30-day Notice
S051 2017-09-07 30-day Notice
S050 2017-08-14 135 Review Track For 30-day Notice
S049 2017-07-26 30-day Notice
S048 2016-11-07 30-day Notice
S047 2016-07-11 30-day Notice
S046 2016-02-18 30-day Notice
S045 2016-02-10 30-day Notice
S044 2015-11-24 30-day Notice
S043 2015-11-16 30-day Notice
S042 2015-10-30 Real-time Process
S041 2015-08-10 135 Review Track For 30-day Notice
S040 2015-03-27 30-day Notice
S039 2014-10-14 30-day Notice
S038 2014-07-25 30-day Notice
S037 2013-12-26 30-day Notice
S036 2013-09-10 30-day Notice
S035 2013-07-08 30-day Notice
S034 2013-07-01 Special (immediate Track)
S033 2013-06-26 30-day Notice
S032 2013-03-28 Normal 180 Day Track No User Fee
S031 2013-03-01 30-day Notice
S030 2012-10-23 30-day Notice
S029 2012-04-26 Normal 180 Day Track No User Fee
S028 2012-03-23 Normal 180 Day Track No User Fee
S027 2012-03-08 Special (immediate Track)
S026 2011-12-13 Normal 180 Day Track No User Fee
S025 2011-10-25 30-day Notice
S024
S023
S022 2010-07-12 Special (immediate Track)
S021 2009-04-23 30-day Notice
S020 2009-03-13 30-day Notice
S019 2008-09-26 Normal 180 Day Track No User Fee
S018 2007-11-28 135 Review Track For 30-day Notice
S017 2007-01-30 Real-time Process
S016 2006-12-15 Normal 180 Day Track
S015
S014 2005-04-07 135 Review Track For 30-day Notice
S013 2004-09-01 Normal 180 Day Track
S012
S011 2004-04-27 Real-time Process
S010 2004-01-30 30-day Notice
S009 2003-08-28 30-day Notice
S008 2003-08-19 30-day Notice
S007 2003-05-20 Real-time Process
S006 2002-05-01 Normal 180 Day Track
S005 2001-09-24 Normal 180 Day Track
S004 2001-03-26 Normal 180 Day Track
S003 2000-10-20 Normal 180 Day Track
S002
S001 2000-10-17 Normal 180 Day Track

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