Edwards Lifesciences L L C One Edwards Wayirvine Ca 92614 Pma Numberp870056 Supplement Numbers002 Date Received10 30 1995 Decision Date12 06 1996 Withdrawal Date 01 28 2022 Product Code Dye Docket Number N Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location 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 Numbers002 Date Received10 30 1995 Decision Date12 06 1996 Withdrawal Date 01 28 2022 Product Code Dye Docket Number N Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location 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 P870056S002 EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS002 Date Received10/30/1995 Decision Date12/06/1996 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number N Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL)	1996-12-06