Edwards Lifesciences

FDA Filings

This page includes the latest FDA filings for Edwards Lifesciences. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K200258 Edwards Lifesciences	Edwards ESheath Introducer Set	2020-03-09
PMN K153069 EDWARDS LIFESCIENCES	Edwards Balloon Catheter	2016-01-07
PMN K152225 EDWARDS LIFESCIENCES	Edwards ESheath Introducer Set	2015-11-24
PMN K142199 EDWARDS LIFESCIENCES	Ascendra Balloon Aortic Valvaloplasty Catheter	2014-10-29
PMN K141696 EDWARDS LIFESCIENCES	EDWARDS ESHEATH INTRODUCER SET	2014-09-18
PMN K110597 EDWARDS LIFESCIENCES	EV1000 CLINICAL PLATFORM	2011-06-14

Similar & Related FDA Registered Companies

Edwards Lifesciences, LLC
EDWARDS LIFESCIENCES SERVICES GMBH
EDWARDS LIFESCIENCES RESEARCH MEDICAL
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS151 Date Received01/05/2023 Decision Date01/20/2023 Product Code NPT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS005 Date Received12/19/2022 Decision Date12/20/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS032 Date Received11/14/2022 Decision Date12/12/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS150 Date Received11/14/2022 Decision Date12/12/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS004 Date Received11/15/2022 Decision Date12/07/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS149 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards 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
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS147 Date Received09/26/2022 Decision Date10/26/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS030 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS148 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS065 Date Received10/12/2022 Decision Date10/19/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS069 Date Received10/12/2022 Decision Date10/19/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS001 Date Received10/12/2022 Decision Date10/19/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS210 Date Received10/12/2022 Decision Date10/19/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS144 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS145 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS027 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS209 Date Received08/25/2022 Decision Date09/23/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS068 Date Received08/25/2022 Decision Date09/23/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS064 Date Received08/25/2022 Decision Date09/23/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Date Received03/14/2022 Decision Date09/14/2022 Product Code NKM Advisory Committee Cardiovascular Clinical TrialsNCT03706833 Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS208 Date Received08/15/2022 Decision Date09/12/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS067 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS063 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS066 Date Received07/25/2022 Decision Date08/01/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS141 Date Received05/02/2022 Decision Date07/28/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS023 Date Received06/30/2022 Decision Date07/25/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS022 Date Received06/06/2022 Decision Date07/06/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS021 Date Received05/25/2022 Decision Date06/23/2022 Product Code NPV Advisory Committee Cardiovascular Clinical TrialsNCT05378386 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS064 Date Received04/06/2022 Decision Date04/26/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS062 Date Received03/22/2022 Decision Date04/20/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS019 Date Received04/04/2022 Decision Date04/08/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS063 Date Received04/06/2022 Decision Date04/08/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS206 Date Received03/08/2022 Decision Date03/31/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS060 Date Received03/08/2022 Decision Date03/31/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS061 Date Received03/08/2022 Decision Date03/31/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	B7564	EDWARDS LIFESCIENCES
CAGE Code	B7564	EDWARDS LIFESCIENCES

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929106113	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL PRODUCTS SLAC 64 PALLETS OF MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE NONE NONE NONE NONE	64 PKG
20200929106113	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL PRODUCTS SLAC 64 PALLETS OF MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE NONE NONE NONE NONE	64 PKG
20200929106113	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL PRODUCTS SLAC 64 PALLETS OF MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE NONE NONE NONE NONE	64 PKG
2020092824520	Panama Canal - Caribbean,Panama -> San Juan, Puerto Rico	HOUSING DPT ANNEALED PO# 20062467-OP PO# 20062194-OP 1#5# 1.26 1.02 1.7M 6# 1.26 1.02 0.76M WOOD PALLET WITH IPPC LOGO HS-CODE 9018909999	322 BOX
2020092458975	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL PRODUCTS SLAC 38 PALLETS OF MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE . NONE NONE NONE	38 PLT
2020092458975	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL PRODUCTS SLAC 38 PALLETS OF MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE . NONE NONE NONE	38 PLT
2020092459535	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	2,390 PACKAGES CONTAINING: DISPOSABLE PRESURE TRANSDUCER SETS FOR MEDICAL USAGE, THE SOLI D WOOD PACKING MATERIALS, FREE FROM LIVES PL ANTS PEST (SWPM) ARE TOTALLY.	2390 BOX
2020092296051	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL DEVICES SLAC 24 PALLETS MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE. 3,346 KG . SLAC 24 PALLETS MEDICAL PRODUCTS FOR MONITORING BLOOD	74 PLT
2020092296051	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL DEVICES SLAC 24 PALLETS MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE. 3,346 KG . SLAC 24 PALLETS MEDICAL PRODUCTS FOR MONITORING BLOOD	74 PLT
2020092296051	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL DEVICE SLAC 26 PALLETS MEDICAL PRODUCTS FOR MONITORING BLOOD PRESS PRESSURE	74 PLT
2020092296900	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	5,937 PACKAGES CONTAINING: DISPOSABLE PRESURE TRANSDUCER SETS FOR MEDICAL USAGE, THE SOLI D WOOD PACKING MATERIALS, FREE FROM LIVES PL ANTS PEST (SWPM) ARE TOTALLY.	5937 PKG

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