Implementation of an updated version of the statistical process control (spc) software system across multiple manufacturing locations and vertically integrated suppliers.
| Device | KAPPA 400 IPG |
| Classification Name | Pulse Generator, Permanent, Implantable |
| Generic Name | Pulse Generator, Permanent, Implantable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2010-10-26 |
| Decision Date | 2010-11-23 |
| PMA | P970012 |
| Supplement | S076 |
| Product Code | NVZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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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