Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication

FDA Premarket Approval P200015 S003

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

Addition of an alternative crimping accessory packaged with the edwards delivery systems

DeviceEdwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLC
Date Received2020-11-17
Decision Date2020-12-16
PMAP200015
SupplementS003
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
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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