Edward Ma

FDA Filings

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

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• 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, 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 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 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, 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 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, 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, 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, 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 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 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 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, 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 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 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, 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 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 92614-5688 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 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 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 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 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 92614-5688 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
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS067 Date Received03/05/2014 Decision Date05/19/2014 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS066 Date Received02/27/2014 Decision Date03/27/2014 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS065 Date Received02/25/2014 Decision Date03/14/2014 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS064 Date Received12/24/2013 Decision Date01/23/2014 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS063 Date Received11/22/2013 Decision Date12/19/2013 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS062 Date Received09/12/2013 Decision Date10/11/2013 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS061 Date Received08/26/2013 Decision Date09/23/2013 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS060 Date Received06/17/2013 Decision Date07/16/2013 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS059 Date Received05/29/2013 Decision Date06/25/2013 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS056 Date Received12/14/2012 Decision Date06/11/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS058 Date Received03/25/2013 Decision Date04/24/2013 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS057 Date Received02/12/2013 Decision Date03/12/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS055 Date Received11/28/2012 Decision Date02/28/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS054 Date Received11/21/2012 Decision Date12/11/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS053 Date Received11/13/2012 Decision Date12/10/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS052 Date Received09/04/2012 Decision Date10/04/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS051 Date Received08/21/2012 Decision Date09/19/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS050 Date Received06/13/2012 Decision Date07/11/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS049 Date Received05/04/2012 Decision Date05/30/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS048 Date Received03/20/2012 Decision Date04/13/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS047 Date Received03/05/2012 Decision Date04/04/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS046 Date Received02/21/2012 Decision Date03/22/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS045 Date Received12/20/2011 Decision Date01/19/2012 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS044 Date Received11/16/2011 Decision Date12/12/2011 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS040 Date Received11/12/2010 Decision Date07/27/2011 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS043 Date Received04/08/2011 Decision Date05/05/2011 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS042 Date Received12/21/2010 Decision Date01/20/2011 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS041 Date Received11/22/2010 Decision Date12/22/2010 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS039 Date Received01/25/2010 Decision Date02/24/2010 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS038 Date Received01/21/2010 Decision Date02/18/2010 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS037 Date Received12/17/2009 Decision Date01/14/2010 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS036 Date Received12/04/2009 Decision Date12/30/2009 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS035 Date Received10/19/2009 Decision Date11/25/2009 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS034 Date Received07/07/2009 Decision Date07/23/2009 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS033 Date Received06/22/2009 Decision Date07/09/2009 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS032 Date Received12/08/2008 Decision Date12/31/2008 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS031 Date Received11/28/2008 Decision Date12/17/2008 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS030 Date Received10/02/2008 Decision Date10/29/2008 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS029 Date Received06/20/2008 Decision Date07/10/2008 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS028 Date Received03/24/2008 Decision Date05/23/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS027 Date Received11/15/2007 Decision Date12/13/2007 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS024 Date Received08/30/2006 Decision Date01/29/2007 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS025 Date Received09/26/2006 Decision Date01/18/2007 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS023 Date Received11/14/2005 Decision Date12/06/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS022 Date Received08/19/2005 Decision Date10/07/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS021 Date Received04/28/2005 Decision Date05/20/2005 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS020 Date Received03/21/2005 Decision Date04/08/2005 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS019 Date Received01/31/2005 Decision Date02/28/2005 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS018 Date Received12/20/2004 Decision Date01/19/2005 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS017 Date Received09/27/2004 Decision Date12/29/2004 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS015 Date Received11/12/2002 Decision Date08/22/2003 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS016 Date Received12/05/2002 Decision Date12/31/2002 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS014 Date Received07/13/2000 Decision Date08/04/2000 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS013 Date Received05/18/2000 Decision Date06/16/2000 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS012 Date Received10/04/1999 Decision Date10/22/1999 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS011 Date Received03/26/1999 Decision Date04/13/1999 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS010 Date Received10/09/1998 Decision Date10/26/1998 Withdrawal Date 01/28/2022 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 NumberP870056 Supplement NumberS006 Date Received02/25/1998 Decision Date08/07/1998 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS002 Date Received10/30/1995 Decision Date12/06/1996 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number N Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS003 Date Received04/17/1996 Decision Date10/17/1996 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Date Received09/24/1987 Decision Date09/25/1991 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number 91M-0395 Notice Date 11/12/1991 Advisory Committee Cardiovascular Expedited Review Granted? No
• Edwards Pharmaceuticals, Inc

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018070357296	Pusan,South Korea -> Long Beach, California	COPPER DOOR PENDANT LAMP	3 PKG