Approval for the medtronic/vitatron carelink programmer model 2090, model 2067 carelink programmer rf head, model 2290 lead analyzer, model 2292 analyzer cable, model 2091 carelink programmer modem, model 8190 software for the model 2290 lead analyzer, model 5437a programmer interface cable, model 2090 ec ecg cable, model 2090 ab cable, model 2090 tps touchpen, model 2090 rv remote view software, model 9964 carelink programmer software for the gem ii dr icd (model 7273), model 9966 carelink programmer software for the marquis dr icd, model 9896 carelink programmer software for the jewel (model 7218), and vitatron model vsc02 version 6. 1 carelink programmer software. In addition, this submission includes the following programmer software applications (previously approved for other medtronic, vitatron, or cpi programmers) that have been modified for use with the model 2090 carelink programmer: vitatron provit model vsa02 v6. 1, kappa 400 (9952/a), kappa 600/700 (9953/a), kappa 800/900 (9988), sigma (9963/a), insync (9980), reveal plus (9809), analyzer (8190), gem (9962), gem dr (9960), gem ii vr (9965), gem ii dr (9964), gem iii vr (9971), gem iii dr (9970), gem iii at (9974), baseline 7 (9891/a), cpi prelude (9892), cpi triumph (9892), jewel pcd (9895), jewel cd (9895), jewel af (9961), jewel plus (9895), pcd (9895), preva d, st-dr (9959, jewel (9894), jewel ii (9955). The device, as modified, will be marketed under the trade name medtronic/ vitatron carelink programmer model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
| Device | KAPPA 400 PACEMAKER FAMILY |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2002-02-27 |
| Decision Date | 2002-03-13 |
| PMA | P970012 |
| Supplement | S013 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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