Edwards Lifesciences L L C 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

FDA Filings

This page includes the latest FDA filings for Edwards Lifesciences L L C 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. 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 P140031S145 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	SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System	2022-09-23