Approval for an update to the medtronic. Vision software model 9952 - series 2. 0. The update will add the ability to program the medtronic. Kappa 400 models k(dr) 401/403, k(sr) 401/403, the medtronic dx2 models 7970/7972, and will add electrophysiological studies (eps) capability to the kappa 400 pacemakers. The update also incorporates performance enhancements which shorten boot and application load times, provide quicker screen transitions, and reporting and usability enhancements.
| Device | MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | MEDTRONIC Inc. |
| Date Received | 1998-04-06 |
| Decision Date | 1998-05-21 |
| PMA | P970012 |
| Supplement | S001 |
| Product Code | DXY |
| 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 |
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