Edwards Lifesciences L L C One Edwards Wayirvine Ca 92614 Pma Numberp870056 Supplement Numbers006 Date Received02 25 1998 Decision Date08 07 1998 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material 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 Numbers006 Date Received02 25 1998 Decision Date08 07 1998 Withdrawal Date 01 28 2022 Product Code Dye Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material 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 P870056S006 EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS006 Date Received02/25/1998 Decision Date08/07/1998 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT	1998-08-07