Approval for the medtronic. Kappa 400 series pacemakers, which includes; medtronic. Kappa kdr 401/403 & ksr 401/403 implantable pulse generators w/medtronic. Vision (model 9952e) software, & medtronic model 9462 remote assistant. These devices are indicated for the following: 1)rate adaptive pacing in patients who may benefit from increased pacing rates concurrent w/increases in activity and/or minute ventilation; 2)accepted patient conditions warranting chronic cardiac pacing which include: a)symptomatic parosysmal or permanent 2nd or 3rd degree av block; b) symptomatic bilateral bundle branch block; c) symptomatic parosysmal or transient sinus node dysfunctions w/ or without associated av conduction disorders; d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) vasovagal syndromes or hypersensitive carotid sinus syndromes. 3) medtronic. Kappa 400 series pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. Dual chamber modes are specifcally indicated for treatment of conduction disorders that require restoration of both rate & av synchrony, which include: a) various degress of av block to maintain the atrial contribution to cardiac output; and b) vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent sinus rhythm.
| Device | MEDTRONIC.KAPPA 400 SERIES PACEMAKERS |
| Classification Name | Pulse Generator, Permanent, Implantable |
| Generic Name | Pulse Generator, Permanent, Implantable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 1997-02-07 |
| Decision Date | 1998-01-30 |
| Notice Date | 1998-04-16 |
| PMA | P970012 |
| Supplement | S |
| Product Code | NVZ |
| Docket Number | 98M-0231 |
| Advisory Committee | Cardiovascular |
| 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