Approval for the wcd 2000 system. This device is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.
| Device | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
| Classification Name | Wearable Automated External Defibrillator |
| Generic Name | Wearable Automated External Defibrillator |
| Applicant | ZOLL MANUFACTURING CORPORATION |
| Date Received | 2001-05-04 |
| Decision Date | 2001-12-18 |
| Notice Date | 2002-04-12 |
| PMA | P010030 |
| Supplement | S |
| Product Code | MVK |
| Docket Number | 02M-0145 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZOLL MANUFACTURING CORPORATION 121 Gamma Dr pittsburgh, PA 15238-0000 |
| Summary: | Summary of Safety and Effectiveness |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010030 | | Original Filing |
| S163 |
2023-01-09 |
30-day Notice |
| S162 | | |
| S161 | | |
| S160 |
2022-08-03 |
30-day Notice |
| S159 |
2022-05-17 |
30-day Notice |
| S158 | | |
| S157 |
2022-01-19 |
30-day Notice |
| S156 |
2021-11-30 |
30-day Notice |
| S155 | | |
| S154 |
2021-10-29 |
30-day Notice |
| S153 |
2021-10-01 |
30-day Notice |
| S152 | | |
| S151 |
2021-06-15 |
Real-time Process |
| S150 |
2021-06-07 |
Real-time Process |
| S149 |
2021-04-30 |
30-day Notice |
| S148 |
2021-04-30 |
30-day Notice |
| S147 |
2021-04-21 |
30-day Notice |
| S146 |
2020-10-29 |
30-day Notice |
| S145 | | |
| S144 | | |
| S143 | | |
| S142 |
2020-09-01 |
30-day Notice |
| S141 | | |
| S140 |
2020-06-22 |
30-day Notice |
| S139 |
2020-06-11 |
30-day Notice |
| S138 | | |
| S137 |
2020-05-04 |
30-day Notice |
| S136 | | |
| S135 |
2020-04-13 |
30-day Notice |
| S134 |
2020-04-01 |
30-day Notice |
| S133 | | |
| S132 |
2020-03-18 |
30-day Notice |
| S131 |
2019-12-19 |
30-day Notice |
| S130 |
2019-12-17 |
30-day Notice |
| S129 |
2019-12-03 |
30-day Notice |
| S128 |
2019-11-13 |
30-day Notice |
| S127 | | |
| S126 |
2019-09-30 |
30-day Notice |
| S125 |
2019-08-29 |
30-day Notice |
| S124 | | |
| S123 |
2019-08-07 |
30-day Notice |
| S122 | | |
| S121 | | |
| S120 |
2019-07-08 |
30-day Notice |
| S119 |
2019-06-27 |
30-day Notice |
| S118 |
2019-05-31 |
30-day Notice |
| S117 |
2019-05-15 |
30-day Notice |
| S116 |
2019-03-13 |
30-day Notice |
| S115 |
2019-02-13 |
30-day Notice |
| S114 |
2019-02-11 |
30-day Notice |
| S113 |
2019-02-07 |
30-day Notice |
| S112 |
2018-12-20 |
30-day Notice |
| S111 |
2018-12-10 |
Real-time Process |
| S110 |
2018-10-01 |
Real-time Process |
| S109 | | |
| S108 |
2018-08-08 |
Special (immediate Track) |
| S107 |
2018-05-04 |
135 Review Track For 30-day Notice |
| S106 |
2018-05-03 |
135 Review Track For 30-day Notice |
| S105 |
2018-04-30 |
30-day Notice |
| S104 |
2018-04-24 |
Real-time Process |
| S103 |
2017-11-13 |
30-day Notice |
| S102 |
2017-11-07 |
Real-time Process |
| S101 |
2017-10-23 |
30-day Notice |
| S100 |
2017-10-20 |
Normal 180 Day Track |
| S099 |
2017-08-24 |
30-day Notice |
| S098 |
2017-06-30 |
Normal 180 Day Track |
| S097 |
2017-05-30 |
Real-time Process |
| S096 | | |
| S095 |
2017-04-03 |
30-day Notice |
| S094 | | |
| S093 | | |
| S092 |
2017-02-07 |
30-day Notice |
| S091 |
2017-01-18 |
Normal 180 Day Track |
| S090 |
2017-01-05 |
Normal 180 Day Track |
| S089 |
2016-12-27 |
30-day Notice |
| S088 |
2016-12-23 |
30-day Notice |
| S087 |
2016-12-12 |
Real-time Process |
| S086 |
2016-10-27 |
Normal 180 Day Track No User Fee |
| S085 |
2016-10-04 |
30-day Notice |
| S084 |
2016-09-28 |
Real-time Process |
| S083 |
2016-09-07 |
30-day Notice |
| S082 | | |
| S081 |
2016-08-31 |
Real-time Process |
| S080 |
2016-08-11 |
30-day Notice |
| S079 |
2016-07-05 |
30-day Notice |
| S078 |
2016-06-23 |
30-day Notice |
| S077 |
2016-06-07 |
30-day Notice |
| S076 |
2016-05-20 |
30-day Notice |
| S075 |
2016-05-13 |
30-day Notice |
| S074 |
2016-04-19 |
Real-time Process |
| S073 |
2016-03-16 |
Real-time Process |
| S072 |
2016-01-27 |
Real-time Process |
| S071 |
2015-11-23 |
30-day Notice |
| S070 |
2015-11-12 |
Real-time Process |
| S069 |
2015-11-03 |
30-day Notice |
| S068 |
2015-10-16 |
Real-time Process |
| S067 |
2015-10-02 |
Normal 180 Day Track |
| S066 |
2015-09-03 |
30-day Notice |
| S065 |
2015-07-27 |
30-day Notice |
| S064 |
2015-07-02 |
Real-time Process |
| S063 |
2015-06-29 |
Real-time Process |
| S062 |
2015-06-04 |
30-day Notice |
| S061 |
2015-04-28 |
30-day Notice |
| S060 |
2015-02-27 |
30-day Notice |
| S059 |
2014-12-22 |
Normal 180 Day Track |
| S058 |
2014-11-13 |
Real-time Process |
| S057 |
2014-10-10 |
30-day Notice |
| S056 |
2013-02-19 |
Panel Track |
| S055 |
2014-07-09 |
30-day Notice |
| S054 |
2014-07-11 |
Real-time Process |
| S053 |
2014-05-27 |
Real-time Process |
| S052 |
2014-05-21 |
Real-time Process |
| S051 |
2014-05-12 |
Real-time Process |
| S050 |
2014-05-08 |
30-day Notice |
| S049 |
2014-03-25 |
Real-time Process |
| S048 |
2014-01-22 |
30-day Notice |
| S047 |
2013-12-23 |
30-day Notice |
| S046 |
2013-11-26 |
30-day Notice |
| S045 |
2013-11-21 |
30-day Notice |
| S044 |
2013-09-03 |
30-day Notice |
| S043 | | |
| S042 |
2013-02-12 |
Normal 180 Day Track |
| S041 |
2013-02-12 |
Real-time Process |
| S040 |
2013-02-05 |
135 Review Track For 30-day Notice |
| S039 |
2012-11-21 |
Real-time Process |
| S038 |
2012-10-22 |
30-day Notice |
| S037 |
2012-10-18 |
Real-time Process |
| S036 |
2012-09-19 |
30-day Notice |
| S035 |
2012-07-17 |
Real-time Process |
| S034 |
2012-05-29 |
Real-time Process |
| S033 |
2012-05-29 |
30-day Notice |
| S032 |
2012-05-14 |
Real-time Process |
| S031 |
2011-10-20 |
Normal 180 Day Track |
| S030 |
2011-09-27 |
30-day Notice |
| S029 |
2011-06-20 |
Real-time Process |
| S028 |
2011-05-10 |
|
| S027 |
2011-03-16 |
Real-time Process |
| S026 |
2011-02-24 |
30-day Notice |
| S025 |
2011-01-03 |
Real-time Process |
| S024 |
2010-09-07 |
Real-time Process |
| S023 |
2010-08-17 |
Normal 180 Day Track |
| S022 |
2010-08-03 |
30-day Notice |
| S021 |
2010-07-20 |
Normal 180 Day Track No User Fee |
| S020 |
2010-05-06 |
30-day Notice |
| S019 |
2009-12-28 |
Real-time Process |
| S018 |
2009-11-02 |
Real-time Process |
| S017 |
2009-11-02 |
30-day Notice |
| S016 |
2009-11-02 |
Real-time Process |
| S015 |
2009-10-30 |
Real-time Process |
| S014 |
2009-10-30 |
30-day Notice |
| S013 |
2009-10-29 |
Real-time Process |
| S012 |
2008-09-15 |
Real-time Process |
| S011 |
2008-09-05 |
Normal 180 Day Track |
| S010 |
2008-02-19 |
Real-time Process |
| S009 |
2007-05-21 |
Real-time Process |
| S008 |
2006-08-11 |
Real-time Process |
| S007 |
2006-03-06 |
Real-time Process |
| S006 |
2004-12-27 |
Real-time Process |
| S005 |
2004-01-21 |
Real-time Process |
| S004 |
2003-07-18 |
Real-time Process |
| S003 |
2002-04-05 |
Normal 180 Day Track |
| S002 |
2002-02-22 |
Real-time Process |
| S001 |
2002-02-07 |
Normal 180 Day Track |
NIH GUDID Devices