Edwards Intuity Valves and Delivery Systems

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P150036 S047

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

DeviceEdwards Intuity Valves and Delivery Systems
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantEDWARDS LIFESCIENCES, LLC.
Date Received2019-11-18
Decision Date2019-11-26
PMAP150036
SupplementS047
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

Supplemental Filings

Supplement NumberDateSupplement Type
P150036Original Filing
S047 2019-11-18 30-day Notice
S046 2019-11-13 30-day Notice
S045 2019-11-01 30-day Notice
S044 2019-10-28 30-day Notice
S043 2019-10-18 30-day Notice
S042
S041 2019-08-27 30-day Notice
S040 2019-05-31 30-day Notice
S039
S038
S037 2019-01-31 30-day Notice
S036 2018-11-16 30-day Notice
S035 2018-11-14 30-day Notice
S034 2018-10-31 30-day Notice
S033 2018-10-24 30-day Notice
S032 2018-07-16 30-day Notice
S031 2018-07-09 30-day Notice
S030 2018-05-25 30-day Notice
S029 2018-04-23 30-day Notice
S028 2018-03-13 30-day Notice
S027 2018-02-28 30-day Notice
S026 2018-02-28 30-day Notice
S025 2018-02-15 30-day Notice
S024 2018-01-09 30-day Notice
S023 2017-12-22 30-day Notice
S022 2017-11-13 135 Review Track For 30-day Notice
S021 2017-11-09 30-day Notice
S020 2017-10-31 30-day Notice
S019 2017-09-27 135 Review Track For 30-day Notice
S018 2017-08-09 30-day Notice
S017 2017-08-03 30-day Notice
S016 2017-07-25 30-day Notice
S015 2017-06-30 30-day Notice
S014 2017-06-22 30-day Notice
S013 2017-06-19 30-day Notice
S012 2017-05-24 30-day Notice
S011 2017-05-12 30-day Notice
S010
S009
S008 2017-04-25 30-day Notice
S007 2017-04-10 30-day Notice
S006 2017-03-23 30-day Notice
S005 2017-01-30 30-day Notice
S004 2017-01-18 30-day Notice
S003 2017-01-11 30-day Notice
S002 2016-12-12 135 Review Track For 30-day Notice
S001 2016-11-15 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00690103194562 P150036 000
00690103194555 P150036 000
00690103194548 P150036 000
00690103194531 P150036 000
00690103194524 P150036 000
00690103194517 P150036 000
00690103194500 P150036 000
00690103194494 P150036 000
00690103194487 P150036 000
00690103194470 P150036 000
00690103192582 P150036 000
00690103192575 P150036 000
00690103192568 P150036 000
00690103192551 P150036 000
00690103194562 P150036 000
00690103192544 P150036 000
00690103194555 P150036 000
00690103194548 P150036 000
00690103194531 P150036 000
00690103194524 P150036 000
00690103194517 P150036 000
00690103194500 P150036 000
00690103194494 P150036 000
00690103194487 P150036 000
00690103194470 P150036 000
00690103192582 P150036 000
00690103192575 P150036 000
00690103192568 P150036 000
00690103192551 P150036 000
00690103192544 P150036 000

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