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

FDA Filings

This page includes the latest FDA filings for 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. 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 P200015S021 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 SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent	2022-06-23