KAPPA 400 DR/SR

Pulse Generator, Permanent, Implantable

FDA Premarket Approval P970012 S040

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 in the barb fastener manufacturing process.

DeviceKAPPA 400 DR/SR
Classification NamePulse Generator, Permanent, Implantable
Generic NamePulse Generator, Permanent, Implantable
ApplicantMEDTRONIC Inc.
Date Received2008-08-11
Decision Date2008-12-24
PMAP970012
SupplementS040
Product CodeNVZ
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P970012Original Filing
S100 2016-11-14 30-day Notice
S099 2016-06-24 Real-time Process
S098 2015-07-02 Real-time Process
S097 2015-04-14 Real-time Process
S096 2014-12-22 Normal 180 Day Track
S095 2014-07-02 Real-time Process
S094 2013-12-19 30-day Notice
S093 2013-04-18 Real-time Process
S092
S091 2012-04-04 Real-time Process
S090 2011-12-20 30-day Notice
S089 2011-09-19 Real-time Process
S088 2011-07-06 30-day Notice
S087 2011-06-28 30-day Notice
S086 2011-06-08 30-day Notice
S085 2011-05-13 30-day Notice
S084 2011-04-29 30-day Notice
S083 2011-02-16 30-day Notice
S082 2011-01-25 30-day Notice
S081
S080 2010-12-10 30-day Notice
S079 2010-11-15 30-day Notice
S078 2010-11-12 30-day Notice
S077 2010-11-09 30-day Notice
S076 2010-10-26 30-day Notice
S075 2010-10-12 30-day Notice
S074 2010-07-28 30-day Notice
S073 2010-07-15 30-day Notice
S072 2010-07-15 30-day Notice
S071 2010-06-28 135 Review Track For 30-day Notice
S070 2010-06-25 30-day Notice
S069 2010-05-20 Real-time Process
S068 2010-05-17 Normal 180 Day Track
S067 2010-05-03 30-day Notice
S066 2010-03-29 30-day Notice
S065 2010-03-01 Real-time Process
S064 2010-02-18 30-day Notice
S063 2010-01-21 30-day Notice
S062 2010-01-13 30-day Notice
S061 2009-12-18 30-day Notice
S060 2009-12-08 30-day Notice
S059 2009-11-23 30-day Notice
S058 2009-10-08 Real-time Process
S057 2009-09-08 30-day Notice
S056 2009-06-17 Real-time Process
S055 2009-06-11 30-day Notice
S054 2009-03-05 30-day Notice
S053 2009-03-02 Normal 180 Day Track
S052 2009-02-18 135 Review Track For 30-day Notice
S051 2009-02-09 135 Review Track For 30-day Notice
S050 2008-12-15 30-day Notice
S049 2008-12-11 30-day Notice
S048 2008-11-26 30-day Notice
S047 2008-11-20 30-day Notice
S046 2008-11-12 30-day Notice
S045 2008-10-17 Real-time Process
S044 2008-09-19 30-day Notice
S043
S042 2008-08-12 30-day Notice
S041 2008-08-11 30-day Notice
S040 2008-08-11 135 Review Track For 30-day Notice
S039 2008-08-04 135 Review Track For 30-day Notice
S038 2008-07-28 Normal 180 Day Track
S037 2008-07-25 135 Review Track For 30-day Notice
S036 2008-06-27 135 Review Track For 30-day Notice
S035 2008-06-18 30-day Notice
S034 2008-03-21 30-day Notice
S033 2008-01-25 30-day Notice
S032 2007-11-19 30-day Notice
S031 2007-10-11 30-day Notice
S030 2007-09-28 Normal 180 Day Track
S029 2007-10-09 30-day Notice
S028 2007-07-26 Real-time Process
S027 2007-03-09 Real-time Process
S026 2006-11-28 30-day Notice
S025 2006-10-17 30-day Notice
S024 2006-07-21 Real-time Process
S023 2006-05-10 135 Review Track For 30-day Notice
S022 2006-02-21 Real-time Process
S021 2006-02-14 Real-time Process
S020 2005-12-09 Normal 180 Day Track
S019 2005-12-08 Real-time Process
S018 2005-10-06 135 Review Track For 30-day Notice
S017
S016 2004-08-27 30-day Notice
S015 2003-08-22 Normal 180 Day Track No User Fee
S014 2002-12-03 Normal 180 Day Track
S013 2002-02-27 Normal 180 Day Track
S012 2001-11-05 Special (immediate Track)
S011 2001-09-24 30-day Notice
S010 2001-02-08 Real-time Process
S009 1999-11-30 Real-time Process
S008 1998-09-24 Normal 180 Day Track
S007
S006 1998-09-22 Real-time Process
S005
S004 1998-08-27 Real-time Process
S003 1998-06-12 30-day Notice
S002 1998-04-13 Normal 180 Day Track
S001 1998-04-06 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00681490199285 P970012 000

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