Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P150048 S041

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

DeviceEdwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
Date Received2019-11-01
Decision Date2019-11-24
PMAP150048
SupplementS041
Product CodeLWR
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 92614-5688

Supplemental Filings

Supplement NumberDateSupplement Type
P150048Original Filing
S042 2019-11-18 30-day Notice
S041 2019-11-01 30-day Notice
S040 2019-10-28 30-day Notice
S039 2019-10-18 30-day Notice
S038 2019-09-17 30-day Notice
S037 2019-08-27 30-day Notice
S036 2019-05-31 30-day Notice
S035 2019-05-30 30-day Notice
S034
S033
S032 2019-03-25 30-day Notice
S031 2019-01-31 30-day Notice
S030 2018-11-14 30-day Notice
S029
S028 2018-10-31 30-day Notice
S027 2018-10-24 30-day Notice
S026 2018-09-07 Normal 180 Day Track No User Fee
S025 2018-07-17 Special (immediate Track)
S024 2018-07-09 30-day Notice
S023 2018-06-26 135 Review Track For 30-day Notice
S022 2018-05-25 30-day Notice
S021 2018-05-24 30-day Notice
S020 2018-04-23 30-day Notice
S019 2018-03-13 30-day Notice
S018 2018-02-28 30-day Notice
S017 2018-02-15 30-day Notice
S016 2018-02-15 30-day Notice
S015 2018-02-06 30-day Notice
S014 2018-02-06 30-day Notice
S013 2018-01-09 30-day Notice
S012 2017-12-01 Panel Track
S011 2017-11-13 135 Review Track For 30-day Notice
S010 2017-11-09 30-day Notice
S009 2017-11-09 135 Review Track For 30-day Notice
S008 2017-11-01 30-day Notice
S007 2017-10-31 30-day Notice
S006 2017-09-27 135 Review Track For 30-day Notice
S005 2017-08-17 135 Review Track For 30-day Notice
S004 2017-08-09 30-day Notice
S003 2017-08-08 Normal 180 Day Track No User Fee
S002 2017-07-27 30-day Notice
S001 2017-07-25 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00690103195019 P150048 000
00690103194975 P150048 000
00690103194982 P150048 000
00690103194999 P150048 000
00690103195002 P150048 000
00690103195019 P150048 000
00690103194968 P150048 000
00690103194975 P150048 000
00690103194982 P150048 000
00690103194999 P150048 000
00690103195002 P150048 000
00690103194968 P150048 000

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