Addition of an alternate supplier (walco corporation; glenshaw, pa) to provide the pre-cut urethane foam (. 500 x. 219) used to cushion the sd card in the lifevest units.
| 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 | 2016-12-27 |
| Decision Date | 2017-01-26 |
| PMA | P010030 |
| Supplement | S089 |
| 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