Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

FDA Premarket Approval P200015 S014

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

Changes to the manufacturing process for several components of the edwards commander delivery system

DeviceEdwards SAPIEN 3 Ultra Transcatheter Heart Valve
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLC
Date Received2021-09-30
Decision Date2021-10-28
PMAP200015
SupplementS014
Product CodeNPV 
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
P200015Original Filing
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

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