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

FDA Filings

This page includes the latest FDA filings for 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. 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 P200015S031 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 SAPIEN 3 Transcatheter Heart Valve System and Accessories	2022-11-16