This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | SYNERGYST PULSE GENERATORS MODEL 7026/7027 |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 1989-03-22 |
| Decision Date | 1989-04-13 |
| PMA | P820003 |
| Supplement | S042 |
| Product Code | LWP |
| 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 CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820003 | Original Filing | |
| S139 | 2022-01-18 | 30-day Notice |
| S138 | 2020-11-05 | Normal 180 Day Track |
| S137 | 2016-11-14 | 30-day Notice |
| S136 | 2016-09-06 | 30-day Notice |
| S135 | 2015-07-02 | Real-time Process |
| S134 | 2015-04-14 | Real-time Process |
| S133 | 2015-03-27 | 30-day Notice |
| S132 | 2014-12-22 | Normal 180 Day Track |
| S131 | 2014-08-27 | 30-day Notice |
| S130 | 2014-07-24 | Real-time Process |
| S129 | 2014-07-02 | Real-time Process |
| S128 | 2014-02-27 | 30-day Notice |
| S127 | 2014-02-27 | 30-day Notice |
| S126 | 2013-12-19 | 30-day Notice |
| S125 | 2013-10-24 | 30-day Notice |
| S124 | ||
| S123 | 2013-07-10 | Normal 180 Day Track No User Fee |
| S122 | 2013-07-10 | 30-day Notice |
| S121 | 2013-05-08 | 30-day Notice |
| S120 | 2013-04-18 | Real-time Process |
| S119 | 2012-11-21 | 30-day Notice |
| S118 | 2012-11-06 | 30-day Notice |
| S117 | 2012-11-29 | Normal 180 Day Track |
| S116 | 2012-04-04 | Real-time Process |
| S115 | 2012-02-29 | 30-day Notice |
| S114 | 2011-11-25 | Real-time Process |
| S113 | 2011-09-19 | Real-time Process |
| S112 | 2011-08-18 | 30-day Notice |
| S111 | 2011-08-08 | 30-day Notice |
| S110 | 2011-07-18 | 30-day Notice |
| S109 | 2011-07-08 | 30-day Notice |
| S108 | 2011-06-28 | 30-day Notice |
| S107 | 2011-06-08 | 30-day Notice |
| S106 | 2011-05-13 | 30-day Notice |
| S105 | 2011-04-26 | 30-day Notice |
| S104 | 2011-01-04 | Normal 180 Day Track |
| S103 | 2010-11-26 | 30-day Notice |
| S102 | 2010-11-12 | 30-day Notice |
| S101 | 2010-10-26 | 30-day Notice |
| S100 | 2010-09-28 | 135 Review Track For 30-day Notice |
| S099 | 2010-10-06 | Real-time Process |
| S098 | 2010-07-19 | 30-day Notice |
| S097 | 2010-07-15 | 30-day Notice |
| S096 | 2010-07-15 | 30-day Notice |
| S095 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S094 | ||
| S093 | 2010-03-01 | Real-time Process |
| S092 | 2009-06-17 | Real-time Process |
| S091 | 2009-03-02 | Normal 180 Day Track |
| S090 | 2009-02-13 | 30-day Notice |
| S089 | 2009-02-06 | 30-day Notice |
| S088 | 2009-01-12 | 30-day Notice |
| S087 | 2008-10-17 | Real-time Process |
| S086 | 2008-09-23 | 135 Review Track For 30-day Notice |
| S085 | 2008-08-27 | Normal 180 Day Track No User Fee |
| S084 | 2008-07-28 | Normal 180 Day Track |
| S083 | ||
| S082 | 2007-09-28 | Normal 180 Day Track |
| S081 | 2007-07-19 | Real-time Process |
| S080 | 2007-07-13 | 30-day Notice |
| S079 | 2007-03-09 | Real-time Process |
| S078 | 2006-02-14 | Real-time Process |
| S077 | 2005-12-22 | Normal 180 Day Track No User Fee |
| S076 | 2005-12-09 | Normal 180 Day Track |
| S075 | 2005-12-08 | Real-time Process |
| S074 | 1999-07-19 | Special (immediate Track) |
| S073 | 1996-06-10 | Normal 180 Day Track |
| S072 | 1996-04-08 | Normal 180 Day Track |
| S071 | 1995-08-10 | Normal 180 Day Track |
| S070 | 1995-02-01 | Normal 180 Day Track |
| S069 | 1994-11-03 | Normal 180 Day Track |
| S068 | 1994-02-22 | Normal 180 Day Track |
| S067 | 1993-06-21 | Normal 180 Day Track |
| S066 | 1993-06-14 | Normal 180 Day Track |
| S065 | 1993-04-06 | Normal 180 Day Track |
| S064 | 1992-07-02 | Normal 180 Day Track |
| S063 | 1992-03-12 | Normal 180 Day Track |
| S062 | 1991-11-22 | Normal 180 Day Track |
| S061 | 1991-11-13 | Normal 180 Day Track |
| S060 | 1991-11-05 | Normal 180 Day Track |
| S059 | 1991-07-29 | Normal 180 Day Track |
| S058 | 1991-01-14 | Normal 180 Day Track |
| S057 | 1991-01-04 | Special (immediate Track) |
| S056 | 1990-11-08 | Normal 180 Day Track |
| S055 | 1990-10-30 | Normal 180 Day Track |
| S054 | 1990-08-24 | Normal 180 Day Track |
| S053 | 1990-08-14 | Normal 180 Day Track |
| S052 | 1990-07-24 | Normal 180 Day Track |
| S051 | 1990-04-02 | Normal 180 Day Track |
| S050 | 1990-03-13 | Normal 180 Day Track |
| S049 | 1990-02-21 | Normal 180 Day Track |
| S048 | 1990-01-29 | Normal 180 Day Track |
| S047 | 1989-11-30 | Normal 180 Day Track |
| S046 | 1989-09-29 | Normal 180 Day Track |
| S045 | 1989-08-17 | Normal 180 Day Track |
| S044 | 1989-08-03 | Normal 180 Day Track |
| S043 | 1989-07-20 | Normal 180 Day Track |
| S042 | 1989-03-22 | Normal 180 Day Track |
| S041 | 1989-01-26 | Normal 180 Day Track |
| S040 | 1988-11-17 | Normal 180 Day Track |
| S039 | 1988-11-08 | Normal 180 Day Track |
| S038 | 1988-10-14 | Normal 180 Day Track |
| S037 | 1988-02-17 | Normal 180 Day Track |
| S036 | 1988-02-11 | Normal 180 Day Track |
| S035 | 1988-01-15 | Normal 180 Day Track |
| S034 | 1987-10-03 | Normal 180 Day Track |
| S033 | 1987-07-22 | Normal 180 Day Track |
| S032 | 1987-06-29 | Normal 180 Day Track |
| S031 | 1987-02-06 | Normal 180 Day Track |
| S030 | 1986-11-17 | Normal 180 Day Track |
| S029 | 1986-06-30 | Normal 180 Day Track |
| S028 | 1986-05-28 | Normal 180 Day Track |
| S027 | 1986-03-19 | |
| S026 | 1986-02-03 | |
| S025 | 1985-12-24 | |
| S024 | 1985-11-08 | |
| S023 | 1985-10-22 | |
| S022 | 1985-09-20 | |
| S021 | 1985-06-25 | |
| S020 | ||
| S019 | 1985-03-14 | |
| S018 | 1985-02-28 | |
| S017 | 1985-02-22 | |
| S016 | 1985-01-04 | |
| S015 | 1984-12-13 | |
| S014 | ||
| S013 | 1984-10-26 | |
| S012 | 1984-10-02 | |
| S011 | 1984-05-29 | |
| S010 | 1984-02-08 | |
| S009 | 1983-12-06 | |
| S008 | 1983-11-10 | |
| S007 | 1983-05-31 | |
| S006 | 1983-05-10 | |
| S005 | 1983-02-14 | |
| S004 | 1983-02-01 | |
| S003 | 1983-01-03 | |
| S002 | 1982-11-17 | |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 20763000181110 | P820003 | 000 |
| 00681490399708 | P820003 | 000 |
| 10721902187077 | P820003 | 000 |
| 10721902187060 | P820003 | 000 |
| 10721902187053 | P820003 | 000 |
| 10721902187046 | P820003 | 000 |
| 20613994524274 | P820003 | 000 |
| 20763000181134 | P820003 | 000 |
| 20613994300083 | P820003 | 072 |
| 00613994521781 | P820003 | 072 |
| 00681490132367 | P820003 | 077 |
| 00613994426550 | P820003 | 077 |
| 00681490132374 | P820003 | 077 |
| 00681490132428 | P820003 | 077 |
| 00681490132435 | P820003 | 077 |
| 20643169431670 | P820003 | 118 |
| 20643169431618 | P820003 | 118 |
| 20643169431656 | P820003 | 118 |
| 20643169307395 | P820003 | 118 |
| 20643169307364 | P820003 | 118 |
| 20643169307388 | P820003 | 118 |
| 20643169307371 | P820003 | 118 |
| 20643169431632 | P820003 | 118 |
| 00643169703254 | P820003 | 130 |
| 00643169703261 | P820003 | 130 |
| 00643169703285 | P820003 | 130 |
| 00643169703346 | P820003 | 130 |
| 00643169703278 | P820003 | 130 |
| 00763000181208 | P820003 | 138 |