This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 1982-01-06 |
| Decision Date | 1982-11-16 |
| Notice Date | 1983-01-07 |
| PMA | P820003 |
| Supplement | S |
| Product Code | LWP |
| Docket Number | 82M-0377 |
| Advisory Committee | Cardiovascular |
| 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 |