ACE Header, Epicardial Patch Lead

FDA Premarket Approval P900061 S157

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

To transfer two incoming inspection activities for device components from medtronic rice creek to medtronic puerto rico operations company villalba/juncos sites

DeviceACE Header, Epicardial Patch Lead
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Date Received2020-02-20
Decision Date2020-03-06
PMAP900061
SupplementS157
Product CodeLWS 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P900061Original Filing
S157 2020-02-20 30-day Notice
S156 2019-11-18 30-day Notice
S155 2019-09-16 30-day Notice
S154 2019-06-10 30-day Notice
S153 2019-04-23 30-day Notice
S152 2019-02-28 30-day Notice
S151 2018-10-23 30-day Notice
S150 2018-10-18 30-day Notice
S149 2018-05-15 30-day Notice
S148 2018-02-22 30-day Notice
S147 2017-11-20 30-day Notice
S146 2017-06-07 30-day Notice
S145 2017-01-17 30-day Notice
S144 2016-11-14 30-day Notice
S143 2016-10-05 30-day Notice
S142 2016-09-22 30-day Notice
S141 2016-09-06 30-day Notice
S140 2016-06-24 30-day Notice
S139 2015-12-28 30-day Notice
S138 2015-12-28 30-day Notice
S137 2015-09-10 30-day Notice
S136 2015-07-02 Real-time Process
S135 2015-04-17 30-day Notice
S134 2015-04-14 Real-time Process
S133 2014-12-22 Normal 180 Day Track
S132 2014-10-15 30-day Notice
S131 2014-08-27 30-day Notice
S130 2014-07-24 30-day Notice
S129 2014-07-02 Real-time Process
S128 2014-02-27 30-day Notice
S127 2014-01-29 30-day Notice
S126 2013-12-19 30-day Notice
S125 2013-12-17 30-day Notice
S124 2013-10-30 30-day Notice
S123 2013-10-24 30-day Notice
S122 2013-05-17 Real-time Process
S121 2013-04-18 Real-time Process
S120 2013-04-10 Normal 180 Day Track No User Fee
S119 2013-03-22 30-day Notice
S118 2012-11-21 30-day Notice
S117 2012-11-13 30-day Notice
S116
S115 2012-08-03 30-day Notice
S114 2012-04-04 Real-time Process
S113 2012-03-26 Real-time Process
S112 2012-02-29 30-day Notice
S111 2011-11-21 Normal 180 Day Track
S110 2011-09-19 Real-time Process
S109 2011-07-28 135 Review Track For 30-day Notice
S108 2011-07-18 30-day Notice
S107 2011-07-08 30-day Notice
S106 2011-07-06 30-day Notice
S105 2011-06-28 30-day Notice
S104 2011-06-08 30-day Notice
S103 2011-05-13 30-day Notice
S102 2011-04-26 30-day Notice
S101 2011-04-12 30-day Notice
S100 2011-03-22 135 Review Track For 30-day Notice
S099 2011-02-28 30-day Notice
S098 2011-01-04 Normal 180 Day Track
S097 2010-11-12 30-day Notice
S096 2010-10-26 30-day Notice
S095
S094 2010-07-15 30-day Notice
S093 2010-07-15 30-day Notice
S092 2010-07-15 30-day Notice
S091 2010-06-28 135 Review Track For 30-day Notice
S090 2010-06-23 30-day Notice
S089 2010-05-20 Real-time Process
S088 2010-03-29 30-day Notice
S087 2010-03-01 Real-time Process
S086 2010-01-19 30-day Notice
S085 2010-01-15 Real-time Process
S084 2009-06-17 Real-time Process
S083 2009-03-02 Normal 180 Day Track
S082 2008-12-22 Normal 180 Day Track No User Fee
S081 2008-12-11 30-day Notice
S080 2008-11-03 30-day Notice
S079 2008-10-17 Real-time Process
S078 2008-08-11 30-day Notice
S077 2008-07-28 Normal 180 Day Track
S076 2008-06-17 30-day Notice
S075 2008-04-14 30-day Notice
S074 2007-09-28 Normal 180 Day Track
S073 2007-08-23 Special (immediate Track)
S072 2007-03-09 Real-time Process
S071 2006-12-01 Normal 180 Day Track No User Fee
S070 2006-11-20 30-day Notice
S069 2006-10-30 Real-time Process
S068 2006-10-30 Normal 180 Day Track No User Fee
S067 2006-10-17 30-day Notice
S066 2006-06-28 Special (immediate Track)
S065 2006-05-10 135 Review Track For 30-day Notice
S064 2006-04-10 Real-time Process
S063 2006-02-21 Real-time Process
S062 2006-02-14 Real-time Process
S061 2006-02-01 Special (immediate Track)
S060 2005-12-09 Normal 180 Day Track
S059 2005-12-08 Real-time Process
S058
S057 2005-09-16 Real-time Process
S056 2002-03-27 Real-time Process
S055 2003-01-27 Real-time Process
S054 2002-12-18 Normal 180 Day Track No User Fee
S053 2002-12-03 Normal 180 Day Track
S052 2002-05-30 Real-time Process
S051 2001-11-05 Special (immediate Track)
S050 2001-10-26 Special (immediate Track)
S049 2001-09-26 Normal 180 Day Track
S048 2001-09-24 30-day Notice
S047 2001-09-07 Real-time Process
S046 2001-07-25 Real-time Process
S045 2001-07-17 30-day Notice
S044 2001-04-17 Real-time Process
S043 2001-02-22 Real-time Process
S042 2001-02-05 Normal 180 Day Track
S041 1999-12-17 Normal 180 Day Track
S040
S039 1999-07-26 Normal 180 Day Track
S038 1999-05-26 Real-time Process
S037 1999-03-31 Normal 180 Day Track
S036 1999-03-08 Normal 180 Day Track
S035 1998-02-17 Normal 180 Day Track
S034 1997-11-17 Normal 180 Day Track
S033 1997-05-19 Normal 180 Day Track
S032 1997-05-05 Normal 180 Day Track
S031 1997-02-18 Normal 180 Day Track
S030 1996-12-23 Normal 180 Day Track
S029 1996-11-18 Normal 180 Day Track
S028 1996-07-15 Normal 180 Day Track
S027 1996-07-15 Normal 180 Day Track
S026
S025
S024 1996-04-24 Normal 180 Day Track
S023 1996-04-03 Normal 180 Day Track
S022 1996-02-15 Normal 180 Day Track
S021 1995-11-02 Normal 180 Day Track
S020 1995-08-25 Normal 180 Day Track
S019 1995-08-14 Normal 180 Day Track
S018 1995-08-10 Normal 180 Day Track
S017 1995-08-01 Normal 180 Day Track
S016 1995-07-19 Normal 180 Day Track
S015 1995-07-18 Normal 180 Day Track
S014 1995-07-03 Normal 180 Day Track
S013 1995-06-26 Normal 180 Day Track
S012 1995-05-30 Normal 180 Day Track
S011 1995-05-30 Normal 180 Day Track
S010 1995-04-11 Special (immediate Track)
S009 1994-12-19 Normal 180 Day Track
S008 1994-10-18 Normal 180 Day Track
S007 1994-05-02 Normal 180 Day Track
S006 1994-04-25 Normal 180 Day Track
S005 1994-04-01 Normal 180 Day Track
S004 1994-03-25 Normal 180 Day Track
S003 1993-09-09 Normal 180 Day Track
S002 1993-04-09 Normal 180 Day Track
S001 1993-02-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00613994534583 P900061 000
00613994534583 P900061 000
00681490148733 P900061 001
00681490148818 P900061 001
00681490148818 P900061 001
00681490148733 P900061 001
00681490148771 P900061 002
00681490148771 P900061 002
00681490132039 P900061 016
00681490132039 P900061 016
00681490149747 P900061 031
00681490149747 P900061 031
20613994647812 P900061 035
20613994647812 P900061 035
00613994520890 P900061 082
00613994520937 P900061 082
00613994520937 P900061 082
00613994520890 P900061 082
00763000059354 P900061 122
00763000059354 P900061 122

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