LifeVest Wearable Defibrillator

Wearable Automated External Defibrillator

FDA Premarket Approval P010030 S128

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Updates to the incoming inspection and returned goods evaluation instructions for the lifevest 4000/hwd 1000 battery packs.

DeviceLifeVest Wearable Defibrillator
Classification NameWearable Automated External Defibrillator
Generic NameWearable Automated External Defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
Date Received2019-11-13
Decision Date2019-11-19
PMAP010030
SupplementS128
Product CodeMVK
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ZOLL MANUFACTURING CORPORATION 121 Gamma Dr pittsburgh, PA 15238-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P010030Original Filing
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

Device IDPMASupp
00855778005043 P010030 001
00855778005050 P010030 001
00855778005005 P010030 011
00855778005012 P010030 011
00855778005029 P010030 011
00855778005036 P010030 011
00855778005128 P010030 011
00855778005111 P010030 025
00855778005135 P010030 059
00855778005159 P010030 067
00855778005173 P010030 067
00855778005180 P010030 067
00855778005203 P010030 067

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