Approval for hardware change to integrate the pendant alarm module into the monitor enclosure, hardware change to the computer/analog printed circuit assembly to improve emi immunity and replace several obsolete components, software changes to interact with the revised computer/analog printed circuit assembly, labeling changes to accommodate the integrated alarm module, and to improve readability, labeling changes to provide a spanish version of the patient manual, patient checklist, and corresponding audio/display messages for spanish speaking patients. The device, as modified, will be marketed under the trade name lifevest wcd 3100 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
| Device | LIFEVEST (WCD 3100) DEVICE |
| Classification Name | Wearable Automated External Defibrillator |
| Generic Name | Wearable Automated External Defibrillator |
| Applicant | ZOLL MANUFACTURING CORPORATION |
| Date Received | 2006-03-06 |
| Decision Date | 2006-11-01 |
| PMA | P010030 |
| Supplement | S007 |
| Product Code | MVK |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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