Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Premarket Approval P140031 S101

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

Implementation of a new cleanroom for receiving inspection processes

DeviceSapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath
Classification NameAortic Valve, Prosthesis, Percutaneously Delivered
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantEDWARDS LIFESCIENCES, LLC.
Date Received2019-11-18
Decision Date2019-11-26
PMAP140031
SupplementS101
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
P140031Original Filing
S101 2019-11-18 30-day Notice
S100 2019-11-01 30-day Notice
S099
S098 2019-10-18 30-day Notice
S097 2019-09-27 30-day Notice
S096 2019-09-16 30-day Notice
S095 2019-09-13 30-day Notice
S094 2019-08-30 Special (immediate Track)
S093
S092
S091 2019-07-22 Real-time Process
S090 2019-07-16 Special (immediate Track)
S089 2019-05-31 30-day Notice
S088 2019-05-28 Real-time Process
S087 2019-05-17 Normal 180 Day Track
S086
S085 2019-04-01 Panel Track
S084 2019-02-22 Special (immediate Track)
S083 2019-02-21 30-day Notice
S082 2019-02-19 30-day Notice
S081 2019-02-08 30-day Notice
S080 2019-01-31 30-day Notice
S079 2018-11-14 30-day Notice
S078 2018-11-09 30-day Notice
S077 2018-10-31 30-day Notice
S076 2018-10-23 30-day Notice
S075 2018-10-18 30-day Notice
S074 2018-09-18 Normal 180 Day Track
S073 2018-08-20 30-day Notice
S072 2018-08-09 30-day Notice
S071 2018-07-11 30-day Notice
S070 2018-07-09 30-day Notice
S069 2018-07-02 30-day Notice
S068 2018-06-28 30-day Notice
S067 2018-05-29 Normal 180 Day Track No User Fee
S066 2018-05-25 30-day Notice
S065 2018-04-23 30-day Notice
S064 2018-04-13 Normal 180 Day Track
S063 2018-03-26 30-day Notice
S062 2018-03-13 30-day Notice
S061 2018-03-05 30-day Notice
S060 2018-03-01 30-day Notice
S059 2018-02-02 30-day Notice
S058 2017-11-20 30-day Notice
S057 2017-11-20 30-day Notice
S056 2017-11-06 30-day Notice
S055 2017-10-31 30-day Notice
S054 2017-09-25 30-day Notice
S053 2017-09-08 30-day Notice
S052 2017-08-23 Normal 180 Day Track
S051 2017-07-03 30-day Notice
S050 2017-06-30 30-day Notice
S049 2017-06-27 30-day Notice
S048 2017-06-22 Normal 180 Day Track No User Fee
S047 2017-06-22 Normal 180 Day Track No User Fee
S046 2017-06-22 30-day Notice
S045 2017-06-19 30-day Notice
S044 2017-06-01 30-day Notice
S043 2017-05-25 30-day Notice
S042 2017-05-24 30-day Notice
S041 2017-04-27 Real-time Process
S040
S039 2017-04-25 30-day Notice
S038 2017-04-10 30-day Notice
S037 2017-03-24 30-day Notice
S036 2017-03-23 30-day Notice
S035 2017-03-23 Real-time Process
S034 2017-03-16 Real-time Process
S033 2017-03-13 Special (immediate Track)
S032 2017-02-13 30-day Notice
S031 2017-01-31 30-day Notice
S030 2017-01-30 30-day Notice
S029 2017-01-11 30-day Notice
S028 2016-12-09 Panel Track
S027 2016-11-18 30-day Notice
S026 2016-11-17 30-day Notice
S025 2016-11-15 135 Review Track For 30-day Notice
S024 2016-08-30 Normal 180 Day Track
S023 2016-08-29 30-day Notice
S022 2016-08-22 30-day Notice
S021 2016-08-12 30-day Notice
S020 2016-08-10 30-day Notice
S019 2016-08-08 30-day Notice
S018 2016-06-06 Normal 180 Day Track No User Fee
S017 2016-05-25 30-day Notice
S016 2016-05-16 Special (immediate Track)
S015 2016-04-22 Normal 180 Day Track No User Fee
S014
S013 2016-04-12 30-day Notice
S012 2016-03-16 30-day Notice
S011 2016-03-01 30-day Notice
S010 2016-02-29 Panel Track
S009 2016-02-18 30-day Notice
S008 2016-02-05 30-day Notice
S007 2016-02-08 Real-time Process
S006 2016-01-15 30-day Notice
S005 2015-12-18 30-day Notice
S004 2015-12-16 30-day Notice
S003 2015-10-07 Normal 180 Day Track
S002 2015-08-19 Normal 180 Day Track No User Fee
S001 2015-07-27 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00690103201444 P140031 074

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