Edwards Lifesciences Llcone Edwards Wayirvine Ca 92614 Pma Numberp220003 Supplement Numbers001 Date Received10 12 2022 Decision Date10 19 2022 Product Code Nkm 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 Numberp220003 Supplement Numbers001 Date Received10 12 2022 Decision Date10 19 2022 Product Code Nkm 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 P220003S001 Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS001 Date Received10/12/2022 Decision Date10/19/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)	2022-10-19