Multiple changes including the addition of an automated test fixture, automation of specific test steps, expansion of test coverage to include the recently approved wcd model 4000b and correction of test limits used in service/rework process.
| Device | LIFEVEST WEARABLE DEFIBRILLATOR |
| Classification Name | Wearable Automated External Defibrillator |
| Generic Name | Wearable Automated External Defibrillator |
| Applicant | ZOLL MANUFACTURING CORPORATION |
| Date Received | 2016-05-20 |
| Decision Date | 2016-06-17 |
| PMA | P010030 |
| Supplement | S076 |
| Product Code | MVK |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZOLL MANUFACTURING CORPORATION 121 Gamma Dr pittsburgh, PA 15238-0000 |
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