Edwards Lifesciences L L C One Edwards Wayirvine Ca 92614 Pma Numberp870056 Supplement Numbers047 Date Received03 05 2012 Decision Date04 04 2012 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 Numberp870056 Supplement Numbers047 Date Received03 05 2012 Decision Date04 04 2012 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P870056S047 EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS047 Date Received03/05/2012 Decision Date04/04/2012 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300	2012-04-04