Edwards Lifesciences Llcone Edwards Wayirvine Ca 92614 Pma Numberp200015 Supplement Numbers023 Date Received06 30 2022 Decision Date07 25 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 Numbers023 Date Received06 30 2022 Decision Date07 25 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 P200015S023 Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS023 Date Received06/30/2022 Decision Date07/25/2022 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 Pulmonic Delivery System	2022-07-25