Edwards Lifesciences L L C One Edwards Wayirvine Ca 92614 Pma Numberp870056 Supplement Numbers028 Date Received03 24 2008 Decision Date05 23 2008 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Typereal Time Process 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 Numbers028 Date Received03 24 2008 Decision Date05 23 2008 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Typereal Time Process 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 P870056S028 EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS028 Date Received03/24/2008 Decision Date05/23/2008 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	CARPENTIER-EDWARDS PERIMOUNT PORCINE BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PORCIN MITRAL BIOPROSTHESIS	2008-05-23