PHYLAX AV ICD SYSTEM

FDA Premarket Approval P980023 S109

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

To optimize the sterilization process parameters for p01 and p02 and propose a load change for p01

DevicePHYLAX AV ICD SYSTEM
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBIOTRONIK, INC.
Date Received2021-09-30
Decision Date2021-10-29
PMAP980023
SupplementS109
Product CodeLWS 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P980023Original Filing
S109 2021-09-30 30-day Notice
S108
S107 2021-07-21 30-day Notice
S106 2021-06-21 30-day Notice
S105 2021-03-16 Real-time Process
S104 2020-11-23 30-day Notice
S103 2020-11-02 30-day Notice
S102 2020-08-10 Real-time Process
S101 2020-03-26 30-day Notice
S100
S099
S098
S097 2019-12-31 30-day Notice
S096
S095 2019-09-17 30-day Notice
S094 2019-08-15 Real-time Process
S093 2019-07-01 Real-time Process
S092 2019-04-23 30-day Notice
S091 2019-03-18 30-day Notice
S090 2018-12-11 Normal 180 Day Track No User Fee
S089 2018-11-23 Real-time Process
S088 2018-11-16 30-day Notice
S087
S086 2018-07-10 30-day Notice
S085 2018-06-14 135 Review Track For 30-day Notice
S084 2018-01-22 30-day Notice
S083 2017-11-20 30-day Notice
S082 2017-11-20 Real-time Process
S081 2017-04-12 Real-time Process
S080 2017-03-07 30-day Notice
S079 2016-11-21 30-day Notice
S078 2016-09-23 30-day Notice
S077 2016-08-01 30-day Notice
S076 2016-06-06 Normal 180 Day Track
S075 2016-05-24 Normal 180 Day Track
S074 2015-12-23 Normal 180 Day Track
S073 2015-08-03 30-day Notice
S072 2015-04-16 Normal 180 Day Track
S071 2015-06-19 Real-time Process
S070 2015-06-17 Normal 180 Day Track No User Fee
S069 2015-06-15 30-day Notice
S068 2015-05-27 30-day Notice
S067 2015-05-22 30-day Notice
S066 2015-04-29 135 Review Track For 30-day Notice
S065 2015-03-06 135 Review Track For 30-day Notice
S064 2015-02-04 30-day Notice
S063 2015-01-08 30-day Notice
S062 2014-09-24 30-day Notice
S061 2014-09-19 30-day Notice
S060 2014-07-28 Normal 180 Day Track
S059 2014-06-23 30-day Notice
S058 2014-05-30 30-day Notice
S057 2014-01-27 Normal 180 Day Track
S056 2013-06-14 Real-time Process
S055 2013-04-29 30-day Notice
S054 2013-04-24 135 Review Track For 30-day Notice
S053 2013-04-22 30-day Notice
S052 2013-04-03 Real-time Process
S051 2013-01-14 30-day Notice
S050 2012-12-21 Real-time Process
S049 2012-11-14 Normal 180 Day Track
S048 2012-09-07 30-day Notice
S047 2012-08-29 30-day Notice
S046 2011-11-14 Normal 180 Day Track
S045
S044 2011-04-11 Real-time Process
S043 2010-12-29 Real-time Process
S042
S041 2010-05-28 Normal 180 Day Track No User Fee
S040 2010-04-13 30-day Notice
S039 2010-02-12 30-day Notice
S038 2009-08-19 Normal 180 Day Track
S037 2008-11-20 Real-time Process
S036 2008-11-17 Normal 180 Day Track
S035 2008-10-31 Real-time Process
S034 2008-06-04 135 Review Track For 30-day Notice
S033 2008-05-21 Real-time Process
S032 2008-05-14 Real-time Process
S031 2008-05-14 Normal 180 Day Track
S030 2008-01-07 Real-time Process
S029 2007-07-13 Normal 180 Day Track
S028 2007-06-25 30-day Notice
S027 2006-12-18 Real-time Process
S026 2006-10-12 Real-time Process
S025 2006-09-11 Normal 180 Day Track
S024 2006-06-29 Real-time Process
S023 2006-06-02 Real-time Process
S022 2006-04-10 135 Review Track For 30-day Notice
S021 2006-03-10 Real-time Process
S020 2005-09-06 Normal 180 Day Track
S019 2004-12-19 Normal 180 Day Track
S018 2004-06-14 Real-time Process
S017 2004-04-02 Normal 180 Day Track
S016 2003-09-15 Real-time Process
S015 2003-07-16 Normal 180 Day Track No User Fee
S014 2003-03-10 Normal 180 Day Track
S013 2003-02-19 Normal 180 Day Track
S012 2003-01-27 Normal 180 Day Track
S011 2002-11-20 30-day Notice
S010 2002-07-22 Real-time Process
S009 2002-06-04 Normal 180 Day Track
S008 2002-04-08 Real-time Process
S007 2002-01-22 Normal 180 Day Track
S006 2002-02-04 Real-time Process
S005 2001-06-25 Normal 180 Day Track
S004 2001-04-27 Normal 180 Day Track
S003 1999-11-02 Normal 180 Day Track
S002 1999-06-01 Real-time Process
S001 1999-02-22 Real-time Process

NIH GUDID Devices

Device IDPMASupp
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04035479140014 P980023 099
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04035479150983 P980023 099

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