Sapien XT Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Premarket Approval P130009 S104

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

Several modifications to the final assembly cleanroom and down classification of gowning room 129 from iso class 7 to iso class 8 at the irvine facility

DeviceSapien XT Transcatheter Heart Valve
Classification NameAortic Valve, Prosthesis, Percutaneously Delivered
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantEDWARDS LIFESCIENCES, LLC.
Date Received2019-11-01
Decision Date2019-11-24
PMAP130009
SupplementS104
Product CodeNPT
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614

Supplemental Filings

Supplement NumberDateSupplement Type
P130009Original Filing
S104 2019-11-01 30-day Notice
S103 2019-10-18 30-day Notice
S102 2019-09-27 30-day Notice
S101
S100 2019-08-30 Special (immediate Track)
S099
S098
S097 2019-02-21 30-day Notice
S096 2019-01-31 30-day Notice
S095 2018-11-14 30-day Notice
S094 2018-10-31 30-day Notice
S093 2018-08-09 30-day Notice
S092 2018-07-09 30-day Notice
S091 2018-06-28 30-day Notice
S090 2018-05-25 30-day Notice
S089 2018-04-23 30-day Notice
S088 2018-03-26 30-day Notice
S087 2018-03-13 30-day Notice
S086 2018-03-05 30-day Notice
S085 2018-03-01 30-day Notice
S084 2018-02-02 30-day Notice
S083 2017-10-31 30-day Notice
S082 2017-09-11 30-day Notice
S081 2017-06-30 30-day Notice
S080 2017-06-27 30-day Notice
S079 2017-06-22 30-day Notice
S078 2017-06-19 30-day Notice
S077 2017-05-25 30-day Notice
S076 2017-05-24 30-day Notice
S075
S074 2017-04-25 30-day Notice
S073 2017-04-10 30-day Notice
S072 2017-03-24 30-day Notice
S071 2017-03-23 30-day Notice
S070 2017-02-13 30-day Notice
S069 2017-01-11 30-day Notice
S068 2016-11-16 Normal 180 Day Track No User Fee
S067 2016-11-17 30-day Notice
S066 2016-11-15 135 Review Track For 30-day Notice
S065 2016-10-11 30-day Notice
S064 2016-08-22 30-day Notice
S063 2016-07-05 30-day Notice
S062 2016-07-01 Normal 180 Day Track No User Fee
S061 2016-06-30 Normal 180 Day Track No User Fee
S060 2016-06-02 Special (immediate Track)
S059 2016-05-25 30-day Notice
S058 2016-05-16 Special (immediate Track)
S057 2016-05-02 Panel Track
S056
S055 2016-04-12 30-day Notice
S054 2016-03-28 Special (immediate Track)
S053 2016-03-23 Normal 180 Day Track No User Fee
S052 2016-03-18 30-day Notice
S051 2016-03-01 30-day Notice
S050 2016-02-18 30-day Notice
S049 2016-02-17 30-day Notice
S048 2016-02-05 30-day Notice
S047 2016-01-20 Special (immediate Track)
S046 2016-01-19 Special (immediate Track)
S045 2016-01-15 30-day Notice
S044 2015-12-14 30-day Notice
S043 2015-12-07 30-day Notice
S042 2015-11-23 30-day Notice
S041 2015-09-30 30-day Notice
S040 2015-07-27 30-day Notice
S039 2015-07-24 30-day Notice
S038 2015-07-10 Real-time Process
S037 2015-07-01 Panel Track
S036 2015-05-22 30-day Notice
S035 2015-05-18 30-day Notice
S034 2015-04-15 Panel Track
S033
S032 2015-03-17 30-day Notice
S031 2015-03-17 30-day Notice
S030
S029 2015-02-18 30-day Notice
S028 2015-02-09 135 Review Track For 30-day Notice
S027 2015-02-02 30-day Notice
S026 2015-01-30 30-day Notice
S025 2015-01-28 30-day Notice
S024 2015-01-13 30-day Notice
S023 2015-01-09 30-day Notice
S022 2015-01-08 30-day Notice
S021
S020
S019 2014-12-03 30-day Notice
S018 2014-11-17 30-day Notice
S017 2014-11-14 30-day Notice
S016 2014-11-13 135 Review Track For 30-day Notice
S015 2014-10-17 30-day Notice
S014 2014-10-10 30-day Notice
S013 2014-10-07 30-day Notice
S012 2014-09-22 30-day Notice
S011 2014-09-04 30-day Notice
S010 2014-09-03 30-day Notice
S009 2014-09-02 30-day Notice
S008
S007
S006
S005 2014-07-21 30-day Notice
S004 2014-07-17 135 Review Track For 30-day Notice
S003 2014-07-15 30-day Notice
S002 2014-07-14 Normal 180 Day Track No User Fee
S001 2014-07-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00690103193763 P130009 000
00690103193756 P130009 000
00690103193749 P130009 000
00690103193732 P130009 000
00690103193725 P130009 000
00690103193718 P130009 000
00690103193466 P130009 000
00690103193442 P130009 000
00690103193237 P130009 000
00690103193220 P130009 000
00690103193176 P130009 000
00690103192117 P130009 000
00690103192100 P130009 000
00690103192087 P130009 000
00690103192070 P130009 000
00690103193763 P130009 000
00690103192063 P130009 000
00690103193756 P130009 000
00690103193749 P130009 000
00690103193732 P130009 000
00690103193725 P130009 000
00690103193718 P130009 000
00690103193466 P130009 000
00690103193442 P130009 000
00690103193237 P130009 000
00690103193220 P130009 000
00690103193176 P130009 000
00690103192117 P130009 000
00690103192100 P130009 000
00690103192087 P130009 000
00690103192070 P130009 000
00690103192063 P130009 000

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