Edwards Lifesciences L L C 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

FDA Filings

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

FDA Filings

Device Company	Device	Date
PMA P140031S151 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 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve	2023-01-20