Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

FDA Premarket Approval P200015 S008

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

To add low ethylene oxide concentration sterilization process (cycle 335) for sterilization of thv devices

DeviceEdwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLC
Date Received2021-02-22
Decision Date2021-03-19
PMAP200015
SupplementS008
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
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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