Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

FDA Premarket Approval P200015 S031

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

DeviceEdwards SAPIEN 3 Transcatheter Heart Valve System and Accessories
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS031 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-25
Decision Date2022-11-16
PMAP200015
SupplementS031
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressEdwards Lifesciences, LLC
one Edwards Way
irvine, CA 92614 PMA NumberP200015 Supplement NumberS031 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Modification To The In-process Acceptance Criteria And Inspection Method For Tissue Separations On The Leaflet Free Edge Of The SAPIEN 3, SAPIEN 3 Ultra, And SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves

Supplemental Filings

Supplement NumberDateSupplement Type
P200015Original Filing
S031 2022-10-25 30-day Notice
S030 2022-10-04 30-day Notice
S029
S028
S027 2022-08-25 30-day Notice
S026
S025
S024
S023 2022-06-30 30-day Notice
S022 2022-06-06 30-day Notice
S021 2022-05-25 Normal 180 Day Track No User Fee
S020
S019 2022-04-04 30-day Notice
S018
S017 2022-01-14 30-day Notice
S016 2021-11-03 Normal 180 Day Track No User Fee
S015 2021-10-19 30-day Notice
S014 2021-09-30 30-day Notice
S013 2021-08-30 30-day Notice
S012 2021-08-25 30-day Notice
S011
S010 2021-06-07 Normal 180 Day Track No User Fee
S009 2021-03-19 Normal 180 Day Track No User Fee
S008 2021-02-22 30-day Notice
S007 2020-12-17 30-day Notice
S006 2020-12-03 30-day Notice
S005
S004 2020-09-08 30-day Notice
S003 2020-11-17 30-day Notice
S002 2020-11-02 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
00690103210866 P200015 011
00690103210873 P200015 011

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