DISPOABLE COVER & EPG SAFETY CABLE

Implantable Pulse Generator, Pacemaker (non-crt)

FDA Premarket Approval P820003 S108

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

Updating a test procedure in response to a new standard.

DeviceDISPOABLE COVER & EPG SAFETY CABLE
Classification NameImplantable Pulse Generator, Pacemaker (non-crt)
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Date Received2011-06-28
Decision Date2011-07-21
PMAP820003
SupplementS108
Product CodeLWP
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
P820003Original Filing
S139 2022-01-18 30-day Notice
S138 2020-11-05 Normal 180 Day Track
S137 2016-11-14 30-day Notice
S136 2016-09-06 30-day Notice
S135 2015-07-02 Real-time Process
S134 2015-04-14 Real-time Process
S133 2015-03-27 30-day Notice
S132 2014-12-22 Normal 180 Day Track
S131 2014-08-27 30-day Notice
S130 2014-07-24 Real-time Process
S129 2014-07-02 Real-time Process
S128 2014-02-27 30-day Notice
S127 2014-02-27 30-day Notice
S126 2013-12-19 30-day Notice
S125 2013-10-24 30-day Notice
S124
S123 2013-07-10 Normal 180 Day Track No User Fee
S122 2013-07-10 30-day Notice
S121 2013-05-08 30-day Notice
S120 2013-04-18 Real-time Process
S119 2012-11-21 30-day Notice
S118 2012-11-06 30-day Notice
S117 2012-11-29 Normal 180 Day Track
S116 2012-04-04 Real-time Process
S115 2012-02-29 30-day Notice
S114 2011-11-25 Real-time Process
S113 2011-09-19 Real-time Process
S112 2011-08-18 30-day Notice
S111 2011-08-08 30-day Notice
S110 2011-07-18 30-day Notice
S109 2011-07-08 30-day Notice
S108 2011-06-28 30-day Notice
S107 2011-06-08 30-day Notice
S106 2011-05-13 30-day Notice
S105 2011-04-26 30-day Notice
S104 2011-01-04 Normal 180 Day Track
S103 2010-11-26 30-day Notice
S102 2010-11-12 30-day Notice
S101 2010-10-26 30-day Notice
S100 2010-09-28 135 Review Track For 30-day Notice
S099 2010-10-06 Real-time Process
S098 2010-07-19 30-day Notice
S097 2010-07-15 30-day Notice
S096 2010-07-15 30-day Notice
S095 2010-06-28 135 Review Track For 30-day Notice
S094
S093 2010-03-01 Real-time Process
S092 2009-06-17 Real-time Process
S091 2009-03-02 Normal 180 Day Track
S090 2009-02-13 30-day Notice
S089 2009-02-06 30-day Notice
S088 2009-01-12 30-day Notice
S087 2008-10-17 Real-time Process
S086 2008-09-23 135 Review Track For 30-day Notice
S085 2008-08-27 Normal 180 Day Track No User Fee
S084 2008-07-28 Normal 180 Day Track
S083
S082 2007-09-28 Normal 180 Day Track
S081 2007-07-19 Real-time Process
S080 2007-07-13 30-day Notice
S079 2007-03-09 Real-time Process
S078 2006-02-14 Real-time Process
S077 2005-12-22 Normal 180 Day Track No User Fee
S076 2005-12-09 Normal 180 Day Track
S075 2005-12-08 Real-time Process
S074 1999-07-19 Special (immediate Track)
S073 1996-06-10 Normal 180 Day Track
S072 1996-04-08 Normal 180 Day Track
S071 1995-08-10 Normal 180 Day Track
S070 1995-02-01 Normal 180 Day Track
S069 1994-11-03 Normal 180 Day Track
S068 1994-02-22 Normal 180 Day Track
S067 1993-06-21 Normal 180 Day Track
S066 1993-06-14 Normal 180 Day Track
S065 1993-04-06 Normal 180 Day Track
S064 1992-07-02 Normal 180 Day Track
S063 1992-03-12 Normal 180 Day Track
S062 1991-11-22 Normal 180 Day Track
S061 1991-11-13 Normal 180 Day Track
S060 1991-11-05 Normal 180 Day Track
S059 1991-07-29 Normal 180 Day Track
S058 1991-01-14 Normal 180 Day Track
S057 1991-01-04 Special (immediate Track)
S056 1990-11-08 Normal 180 Day Track
S055 1990-10-30 Normal 180 Day Track
S054 1990-08-24 Normal 180 Day Track
S053 1990-08-14 Normal 180 Day Track
S052 1990-07-24 Normal 180 Day Track
S051 1990-04-02 Normal 180 Day Track
S050 1990-03-13 Normal 180 Day Track
S049 1990-02-21 Normal 180 Day Track
S048 1990-01-29 Normal 180 Day Track
S047 1989-11-30 Normal 180 Day Track
S046 1989-09-29 Normal 180 Day Track
S045 1989-08-17 Normal 180 Day Track
S044 1989-08-03 Normal 180 Day Track
S043 1989-07-20 Normal 180 Day Track
S042 1989-03-22 Normal 180 Day Track
S041 1989-01-26 Normal 180 Day Track
S040 1988-11-17 Normal 180 Day Track
S039 1988-11-08 Normal 180 Day Track
S038 1988-10-14 Normal 180 Day Track
S037 1988-02-17 Normal 180 Day Track
S036 1988-02-11 Normal 180 Day Track
S035 1988-01-15 Normal 180 Day Track
S034 1987-10-03 Normal 180 Day Track
S033 1987-07-22 Normal 180 Day Track
S032 1987-06-29 Normal 180 Day Track
S031 1987-02-06 Normal 180 Day Track
S030 1986-11-17 Normal 180 Day Track
S029 1986-06-30 Normal 180 Day Track
S028 1986-05-28 Normal 180 Day Track
S027 1986-03-19
S026 1986-02-03
S025 1985-12-24
S024 1985-11-08
S023 1985-10-22
S022 1985-09-20
S021 1985-06-25
S020
S019 1985-03-14
S018 1985-02-28
S017 1985-02-22
S016 1985-01-04
S015 1984-12-13
S014
S013 1984-10-26
S012 1984-10-02
S011 1984-05-29
S010 1984-02-08
S009 1983-12-06
S008 1983-11-10
S007 1983-05-31
S006 1983-05-10
S005 1983-02-14
S004 1983-02-01
S003 1983-01-03
S002 1982-11-17
S001

NIH GUDID Devices

Device IDPMASupp
20763000181110 P820003 000
00681490399708 P820003 000
10721902187077 P820003 000
10721902187060 P820003 000
10721902187053 P820003 000
10721902187046 P820003 000
20613994524274 P820003 000
20763000181134 P820003 000
20613994300083 P820003 072
00613994521781 P820003 072
00681490132367 P820003 077
00613994426550 P820003 077
00681490132374 P820003 077
00681490132428 P820003 077
00681490132435 P820003 077
20643169431670 P820003 118
20643169431618 P820003 118
20643169431656 P820003 118
20643169307395 P820003 118
20643169307364 P820003 118
20643169307388 P820003 118
20643169307371 P820003 118
20643169431632 P820003 118
00643169703254 P820003 130
00643169703261 P820003 130
00643169703285 P820003 130
00643169703346 P820003 130
00643169703278 P820003 130
00763000181208 P820003 138
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