Edwards Lifesciences L L C 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

FDA Filings

This page includes the latest FDA filings for Edwards Lifesciences L L C 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. 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 P140031S141 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 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve	2022-07-28