CapSure Epicardial Pacing Lead

FDA Premarket Approval P950024 S092

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 change to the lead serial number ink/foil material for select implantable leads.

DeviceCapSure Epicardial Pacing Lead
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantMEDTRONIC Inc.
Date Received2020-03-23
Decision Date2020-06-02
PMAP950024
SupplementS092
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P950024Original Filing
S092 2020-03-23 Real-time Process
S091 2020-02-20 30-day Notice
S090 2019-11-18 30-day Notice
S089
S088 2019-09-16 30-day Notice
S087 2019-07-01 30-day Notice
S086 2019-06-21 30-day Notice
S085 2019-06-10 30-day Notice
S084 2019-02-28 30-day Notice
S083 2018-11-21 30-day Notice
S082 2018-10-23 30-day Notice
S081 2018-10-18 30-day Notice
S080 2018-09-26 30-day Notice
S079 2018-05-15 30-day Notice
S078 2018-02-22 30-day Notice
S077 2017-11-20 30-day Notice
S076 2017-10-20 30-day Notice
S075 2017-08-07 30-day Notice
S074 2017-06-28 30-day Notice
S073 2017-06-07 30-day Notice
S072 2017-01-17 30-day Notice
S071 2016-11-28 30-day Notice
S070 2016-11-14 30-day Notice
S069 2016-10-05 30-day Notice
S068 2016-06-24 30-day Notice
S067 2015-12-28 30-day Notice
S066 2015-12-22 30-day Notice
S065 2015-09-10 30-day Notice
S064 2015-04-17 30-day Notice
S063 2014-08-27 30-day Notice
S062 2014-08-13 30-day Notice
S061 2014-07-24 30-day Notice
S060 2014-07-14 30-day Notice
S059 2014-02-27 30-day Notice
S058 2014-01-29 30-day Notice
S057 2013-12-24 30-day Notice
S056 2013-12-19 30-day Notice
S055 2013-11-27 30-day Notice
S054 2013-10-30 30-day Notice
S053 2013-10-24 30-day Notice
S052 2013-09-30 30-day Notice
S051 2013-09-17 30-day Notice
S050 2013-05-17 Real-time Process
S049 2013-04-30 30-day Notice
S048 2013-04-10 Normal 180 Day Track No User Fee
S047 2013-03-22 30-day Notice
S046 2012-11-21 30-day Notice
S045 2012-09-28 30-day Notice
S044 2012-09-14 Normal 180 Day Track No User Fee
S043 2012-09-04 30-day Notice
S042 2012-08-03 30-day Notice
S041 2012-02-29 30-day Notice
S040 2011-12-09 Normal 180 Day Track No User Fee
S039 2011-11-25 30-day Notice
S038 2011-11-21 Normal 180 Day Track
S037 2011-10-24 135 Review Track For 30-day Notice
S036 2011-08-17 30-day Notice
S035 2011-07-18 30-day Notice
S034 2011-07-08 30-day Notice
S033 2011-06-28 30-day Notice
S032 2011-06-08 30-day Notice
S031 2011-04-26 30-day Notice
S030 2011-04-12 30-day Notice
S029 2011-03-22 135 Review Track For 30-day Notice
S028 2011-02-28 30-day Notice
S027 2010-11-12 30-day Notice
S026 2010-10-26 30-day Notice
S025
S024 2010-07-15 30-day Notice
S023 2010-07-15 30-day Notice
S022 2010-07-15 30-day Notice
S021 2010-06-28 135 Review Track For 30-day Notice
S020 2010-03-29 30-day Notice
S019 2010-01-19 30-day Notice
S018 2010-01-15 Real-time Process
S017 2009-02-25 Normal 180 Day Track No User Fee
S016 2009-02-05 30-day Notice
S015 2008-12-11 30-day Notice
S014
S013 2008-11-03 30-day Notice
S012
S011 2008-06-17 30-day Notice
S010 2008-04-14 30-day Notice
S009 2008-03-10 135 Review Track For 30-day Notice
S008 2006-05-10 135 Review Track For 30-day Notice
S007 2005-12-30 Normal 180 Day Track No User Fee
S006 2002-12-24 Real-time Process
S005 2001-11-05 Special (immediate Track)
S004 2001-07-17 30-day Notice
S003 1998-07-27 Normal 180 Day Track
S002 1998-07-01 Normal 180 Day Track
S001 1998-04-20 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00681490116503 P950024 000
00681490116336 P950024 000
00681490116336 P950024 000
00681490116503 P950024 000
00681490116725 P950024 002
00681490116725 P950024 002
00613994501776 P950024 017
00613994501745 P950024 017
00613994501721 P950024 017
00613994492340 P950024 017
00613994492302 P950024 017
00613994501813 P950024 017
00613994501813 P950024 017
00613994492272 P950024 017
00613994492302 P950024 017
00613994492340 P950024 017
00613994501721 P950024 017
00613994501745 P950024 017
00613994501776 P950024 017
00613994492272 P950024 017

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