Edwards Lifesciences L L C One Edwards Wayirvine Ca 92614 Pma Numberp870056 Supplement Numbers055 Date Received11 28 2012 Decision Date02 28 2013 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Type135 Review Track For 30 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 L L C One Edwards Wayirvine Ca 92614 Pma Numberp870056 Supplement Numbers055 Date Received11 28 2012 Decision Date02 28 2013 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Type135 Review Track For 30 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 P870056S055 EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS055 Date Received11/28/2012 Decision Date02/28/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS	2013-02-28