Approval for an update to the operating system software for the carelink programmer associated with medtronic pacemaker, implantable cardioverter defibrillator (icd), and cardiac resynchronization therapy (crt) devices approved under the referenced pma.
| Device | KAPPA 400 IPG |
| Classification Name | Pulse Generator, Permanent, Implantable |
| Generic Name | Pulse Generator, Permanent, Implantable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2011-09-19 |
| Decision Date | 2011-11-17 |
| PMA | P970012 |
| Supplement | S089 |
| Product Code | NVZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne mounds View, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970012 | | Original 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